RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Q: Who is the manufacturer of RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

Myco Medical Supplies, Inc. filed the 510(k) submission for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668).

Q: What is the FDA product code for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

BSP. It is classified under 21 CFR 868.5150 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

Dr J Spinal and Epidural Needles (K183316).

Q: Who can help prepare an FDA 510(k) submission like RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K203668 · Myco Medical Supplies, Inc. · BSP · Sep 29, 2021 · Anesthesiology

Device Facts

Record ID	K203668
Device Name	RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
Applicant	Myco Medical Supplies, Inc.
Product Code	BSP · Anesthesiology
Decision Date	Sep 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

Device Story

Single-lumen spinal and epidural needles; stainless-steel cannula and stylet; polycarbonate hub; detachable wing (epidural). Spinal needles feature Quincke or pencil-point tips; epidural needles feature Tuohy (Huber) tips. Device incorporates ISO 80369-6 compliant NRFit connector to prevent cross-connection with luer-based devices. Used by clinicians in clinical settings to deliver regional anesthesia; spinal needles inject anesthetic into subarachnoid space; epidural needles inject into epidural space, often for catheter placement. Output is the delivery of anesthetic agent to block afferent nerve signals, eliminating pain for procedures below the upper abdomen. Benefits include reduced risk of misconnection, minimized coring/trauma, and enhanced tactile feedback during insertion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1, -4, -5, -10, -11, -18), functional performance (ISO 7864, ISO 9626), and connector-specific testing (ISO 80369-6).

Technological Characteristics

Materials: JIS G4305-SUS304 stainless steel (cannula), JIS G4314-SUS304 stainless steel (stylet), polycarbonate (hub). Connector: ISO 80369-6 compliant. Sterilization: Ethylene Oxide (EtO) per ISO 11135, SAL 10^-6. Cannula depth markings applied via electrolysis. No software or electronic components.

Indications for Use

Indicated for adult and pediatric patients requiring regional anesthesia via injection of local anesthetics into the subarachnoid or epidural space.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

Dr J Spinal and Epidural Needles (K183316)

Reference Devices

Dr. Japan's Phoenix Brand Spinal and Epidural Needles (K990519)
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked (K142553)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 29, 2021 MYCO Medical Supplies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Ave. Crofton, Maryland 21114 ## Re: K203668 Trade/Device Name: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: August 30, 2021 Received: August 31, 2021 Dear E.J. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Todd Courtnev Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 29 #### 510(k) Number (if known) #### Device Name RELI® NRFit® Spinal Needles, RELI® NRFit®Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles #### Indications for Use (Describe) Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510k Summary K203668 | SPONSOR | | | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--| | Company Name: | MYCO Medical | | | Company Address: | 2015 Production Drive | | | | Apex, NC 27539 | | | Telephone: | 919-460-2535 | | | Contact Person: | Sanjiv Kumar | | | Summary Preparation Date: | September 24, 2021 | | | DEVICE NAME | | | | Trade Name: | RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles | | | Common/Usual Name: | Needle, Hypodermic, Single Lumen | | | Classification Name: | Anesthesia Conduction Needle | | | Regulation Number: | 21 CFR 868.5150 | | | Product Code: | BSP | | | Device Class: | II | | ## PREDICATE DEVICE Legally Marketed Equivalent Devices | | K Number | Brand Name | Manufacturer | |-----------|----------|------------------------------------------------------------------------------------|-----------------------------| | Primary | K183316 | Dr J Spinal and Epidural Needles | Dr. Japan | | Reference | K990519 | Dr. Japan's Phoenix Brand Spinal and Epidural Needles | Myco Medical Supplies, Inc. | | Reference | K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked | Unisis Corp. | #### DEVICE DESCRIPTION RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use. The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards. RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration. Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in {4}------------------------------------------------ sterile and non-sterile packaging. Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging. The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths. Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging. ## DEVICE INDICATIONS FOR USE Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia. | | Subject New Device Myco Medical Supplies, Inc. | Primary Predicate Dr. Japan | Reference Predicate Myco Medical Supplies, Inc. | Reference Predicate Unisis Corp. | Similarities and Differences | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------| | K Number | | K183316 | K990519 | K142553 | | | Brand Name | RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles | Dr J Spinal and Epidural Needles | Dr. Japan's Phoenix Epidural and Spinal Needles | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle | | | Regulation Description | Anesthesia conduction needle | Anesthesia conduction | Anesthesia conduction needle | Anesthesia conduction needle | Same | | Regulation No. | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 | Same | | Product Code | BSP | BSP | BSP | BSP | Same | #### COMPARISON OF TECHNILOGICAL CHARACTERISTICS {5}------------------------------------------------ | | Subject New Device Myco Medical Supplies, Inc. | Primary Predicate Dr. Japan | Reference Predicate Myco Medical Supplies, Inc. | Reference Predicate Unisis Corp. | Similarities and Differences | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia. | Dr. J Spinal and Epidural needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia | Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia | The Uniever Disposable Epidural Anesthesia Needle is intended to be used for injection into the epidural space / or placing the epidural catheter into the epidural space. Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control. | Same | | Device Design | | | | | | | Needle Hub | NRFit® connector conforming to ISO 80369-6 for neuraxial device | Hub luer taper connector conforming to ISO 80369-7 | Hub luer taper connector conforming to ISO 594 | Hub luer taper connector conforming to ISO 594 | Different The subject device differs from the predicates only in hub dimensions. ISO 80369-6 specifies a 6% taper hub vs. 5% taper hub in ISO 80369-7 (ISO 594). | | | Subject New Device Myco Medical Supplies, Inc. | Primary Predicate Dr. Japan | Reference Predicate Myco Medical Supplies, Inc. | Reference Predicate Unisis Corp. | Similarities and Differences | | Operating Principle, Spinal Needle | Spinal anesthesia is a form of regional anesthesia involving the injection of a local anesthetic into the subarachnoid space through a spinal needle. Regardless of the anesthetic agent used, the desired effect is to block the transmission of afferent nerve signals from peripheral nociceptors. Sensory signals from the site are blocked, thereby eliminating pain. Spinal anesthetics are typically limited to procedures involving most structures below the upper abdomen. To administer a spinal anesthetic to higher levels may affect the ability to breathe by paralyzing the intercostal respiratory muscles, or even the diaphragm in extreme cases, as well as the body's ability to control the heart rate via the cardiac accelerator fibers. | Spinal anesthesia is a form of regional anesthesia involving the injection of a local anesthetic into the subarachnoid space through a spinal needle. Regardless of the anesthetic agent used, the desired effect is to block the transmission of afferent nerve signals from peripheral nociceptors. Sensory signals from the site are blocked, thereby eliminating pain. | Spinal anesthesia is a form of regional anesthesia involving the injection of a local anesthetic into the subarachnoid space through a spinal needle. Regardless of the anesthetic agent used, the desired effect is to block the transmission of afferent nerve signals from peripheral nociceptors. Sensory signals from the site are blocked, thereby eliminating pain. Spinal anesthetics are typically limited to procedures involving most structures below the upper abdomen. To administer a spinal anesthetic to higher levels may affect the ability to breathe by paralyzing the intercostal respiratory muscles, or even the diaphragm in extreme cases, as well as the body's ability to control the heart rate via the cardiac accelerator fibers. | Spinal anesthesia is a form of regional anesthesia involving the injection of a local anesthetic into the subarachnoid space through a spinal needle. Regardless of the anesthetic agent used, the desired effect is to block the transmission of afferent nerve signals from peripheral nociceptors. Sensory signals from the site are blocked, thereby eliminating pain. Spinal anesthetics are typically limited to procedures involving most structures below the upper abdomen. To administer a spinal anesthetic to higher levels may affect the ability to breathe by paralyzing the intercostal respiratory muscles, or even the diaphragm in extreme cases, as well as the body's ability to control the heart rate via the cardiac accelerator fibers. | Same | | | Subject New Device Myco Medical Supplies, Inc. | Primary Predicate Dr. Japan | Reference Predicate Myco Medical Supplies, Inc. | Reference Predicate Unisis Corp. | Similarities and Differences | | Operating Principle, Epidural Needle | Epidural anesthesia is a regional anesthesia that blocks pain in a particular region of the body. An epidural needle is used to inject local anesthetic agent into the epidural space of the spinal cord to block the pain. To provide continuous epidural anesthesia, a small hollow catheter is threaded through the epidural needle into the epidural space and left there while the needle is removed. | Epidural anesthesia is a regional anesthesia that blocks pain in a particular region of the body. An epidural needle is used to inject local anesthetic agent into the epidural space of the spinal cord to block the pain. To provide continuous epidural anesthesia, a small hollow catheter is threaded through the epidural needle into the epidural space and left there while the needle is removed. | Epidural anesthesia is a regional anesthesia that blocks pain in a particular region of the body. An epidural needle is used to inject local anesthetic agent into the epidural space of the spinal cord to block the pain. To provide continuous epidural anesthesia, a small hollow catheter is threaded through the epidural needle into the epidural space and left there while the needle is removed. | Epidural anesthesia is a regional anesthesia that blocks pain in a particular region of the body. An epidural needle is used to inject local anesthetic agent into the epidural space of the spinal cord to block the pain. To provide continuous epidural anesthesia, a small hollow catheter is threaded through the epidural needle into the epidural space and left there while the needle is removed. | Same | | Intended Patient Population | Adult and child | Adult and child | Adult and child | Not Specified | Same, though Unisis device patient population is not specified. | | Material Specifications | | | | | | | Needle/ Cannula material | Cold-rolled stainless steel (JIS G4305-SUS304) | Cold-rolled stainless steel (JIS G4305- SUS304) | Cold-rolled stainless steel (JIS G4305-SUS304) | Stainless steel SUS304 | Same | | Cannula depth markings | The system to cause a chemical change of the metal ion on the surface to a black color by electrolysis without changing the material of cannula. | The system to cause a chemical change of the metal ion on the surface to a black color by electrolysis without changing the material of cannula. | The system to cause a chemical change of the metal ion on the surface to a black color by electrolysis without changing the material of cannula. | Cannula depth markings are present | Same | | Stylet material | Stainless steel wire for spring (JIS G4314-SUS304) | Stainless steel wire for spring (JIS G4314- SUS304) | Stainless steel wire for spring (JIS G4314-SUS304) | Plastic | Same Different for Unisis Epidural Needle | | Hub material | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Same | | | Subject New Device Myco Medical Supplies, Inc. | Primary Predicate Dr. Japan | Reference Predicate Myco Medical Supplies, Inc. | Reference Predicate Unisis Corp. | Similarities and Differences | | Gauge length/color depiction | Per ISO 6009 | Per ISO 6009 | Per ISO 6009 | Per ISO 6009 | Same | | Plunger/ Stylet Hub | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Same | | Final Needle assembly protection | Protector (polyethylene) | Protector (polyethylene) | Protector (polyethylene) | Protective Sheath | Same | | Sterilization Method | Supplied Sterile via EtO and Non-sterile intended to be sterilized via EtO prior to end use. •ISO 11135 •SAL 10-6 •Maximum EO residual levels comply with ISO 10993-7 | Sterile EO (=ETO) per ISO 11135:2014 SAL 10-6 Maximum EO levels comply with ISO 10993-7:2008…

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Device Facts

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Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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