STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
Device Facts
| Record ID | K112904 |
|---|---|
| Device Name | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS |
| Applicant | Case Medical, Inc. |
| Product Code | FRG · General Hospital |
| Decision Date | Jan 24, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The SteriTite Universal Container System, with MediTray products, is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads.
Device Story
SteriTite Universal Container System; rigid reusable container for sterilization, transport, and storage of medical instruments. Composed of anodized aluminum, passivated stainless steel hardware, silicone gaskets, and disposable polypropylene filters. Used in healthcare facilities; operated by sterile processing staff. Instruments placed in MediTray baskets/trays/inserts within container; container sealed with filter-retention lid. Subjected to Amsco V-PRO 1 Plus or V-PRO maX low-temperature sterilization cycles. Protects instruments from contamination post-sterilization; maintains sterility during storage/transport. Healthcare providers retrieve instruments from container for surgical use. Benefits include standardized instrument organization, protection during handling, and validated sterility maintenance.
Clinical Evidence
Bench testing only. Validation performed at independent laboratories per FDA guidance and AAMI standards. Testing included material compatibility after 100 cycles, 30-day real-time shelf-life testing with handling events, and validation of sterilization efficacy using inoculated product, insert boxes, multilevel tray systems, and various flexible/rigid lumen configurations.
Technological Characteristics
Materials: Anodized aluminum, passivated stainless steel, silicone gaskets, disposable non-woven polypropylene filters. Design: Rigid, reusable container with perforated base and lid, latching mechanism, tamper-evident seals. Connectivity: None. Sterilization: Low-temperature hydrogen peroxide gas plasma (Amsco V-PRO systems).
Indications for Use
Indicated for use by healthcare providers to enclose medical devices, including full instrument sets and mixed loads, for sterilization, transport, and storage. Compatible with Amsco V-PRO 1 Plus (Lumen/Non-lumen cycles) and Amsco V-PRO maX (Lumen/Non-lumen/Flexible cycles). Supports sterilization of rigid lumens (≥3mm diameter, ≤400mm length) and flexible endoscopes (single/dual lumen, ≥1mm diameter, ≤1050mm length).
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Predicate Devices
- SteriTite® universal container system (K090068)
Submission Summary (Full Text)
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K112904
# JAN 2 4 2012
### 5. 510(K) Summary of Safety and Effectiveness
# SteriTite Universal Container System with MediTray Products for Amsco V-PRO 1 Plus and AMSCO V-PRO Max, in Non-lumen and Flexible Cycle
| Date Prepared: | 9/25/11 |
|----------------|--------------------------------------------------------------------|
| Company Name: | Case Medical, Inc.<br>19 Empire Blvd<br>South Hackensack, NJ 07606 |
| Contact: | Tania Lupu<br>Phone: 201-313-1999 ext.229<br>Fax: 201-373-9090<br>Email: tlupu@casemed.com |
|----------|--------------------------------------------------------------------------------------------|
|----------|--------------------------------------------------------------------------------------------|
| Trade Name: | SteriTite® Universal Container System & MediTray Products |
|------------------------------------|-----------------------------------------------------------|
| Common Name: | Sterilization container with disposable filter. |
| Regulation number: | 880.6850 |
| Classification name: | Sterilization Wrap |
| Class of Device: | Class II device |
| Product Code: | 80FRG |
| Review Panel: | General Hospital |
| Establishment Registration Number: | 2248608 |
#### 5.1 Substantial Equivalence:
Case Medical believes that the SteriTite universal container system with MediTray Products for Amsco V-PRO 1 Plus and V-PRO Max, in Non-lumen and Flexible Cycle is substantially equivalent to:
- SteriTite® universal container system -anodized- previously cleared for Amsco V-PRO 1 . Lumen cycle, 510(K) #K090068.
#### 5.2 Description of the Device:
The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with
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passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.
#### 5.3 Indications for Use:
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle and the lumen cycle previously cleared. The SteriTite container has been validated with inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions and inoculated flexible lumens. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite container system is recommended to be used for sterilization of surfaces and lumens:
- 30 days of real time Shelf life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle.
- Reuse testing / Material Compatibility was performed after 100 of AMSCO V-PRO 1 lumen . cycles.
SteriTite universal container system is recommended to be used for sterilization of surfaces and rigid or flexible lumens:
| Sterilizer | Cycle | Rigid lumens 3mm<br>diameter or > and<br>400 mm long or < | Flexible lumens 1mm<br>diameter or > and<br>1050mm long or < | Surfaces |
|-----------------------|-----------------|-----------------------------------------------------------|--------------------------------------------------------------|----------|
| Amsco V-PRO<br>1 Plus | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| Amsco V-PRO<br>Max | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| | Flexible cycle | | X | |
Table 1: SteriTite Universal Container System in AMSCO V-PRO sterilization.
Lumen cycle parameters are the same for all three sterilizer models Note: Non-Lumen cycle parameters are the same for the last two sterilizer models
SteriTite universal container system is recommended for use in:
### 1. V-PRO 1 Plus sterilizer in:
- Non-lumen cycles to sterilize non luments including non-lumened rigid endoscopes . and non-lumened hinged instruments like forceps or scissors.
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- Lumen cycles to sterilize Instruments with diffusion restricted areas such as the hinged portion of . forceps and scissors and medical devices, including rigid endoscopes, with a single stainless steel lumen with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
# 2. V-PRO maX sterilizer in:
- Non-lumen cycles to sterilize non lumened instruments including non-lumened rigid endoscopes . and non-lumened hinged instruments like forceps or scissors.
- Lumen cycles to sterilize Instruments with diffusion restricted areas such as the hinged portion of . forceps and scissors and medical devices, including rigid endoscopes, with a single stainless steel lumen with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
- . Flexible cycle to sterilize single or dual lumen surgical flexible endoscopes in either of two load configuration (per sterilizer manufacturer instruction):
- a. Two flexible endoscopes and no additional load, each having either:
- a single lumen with an inside diameter of 1mm or larger and a length of . .- 1050mm or shorter or
- two lumens with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter and the second one an inside diameter of I mm or larger and a length of 850mm or shorter.
- b. One flexible endoscope and load, each having either:
- . a single lumen with an inside diameter of 1mm or larger and a length of 1050mm or shorter or
- two lumens with one having an inside diameter of 1 mm or larger and a . length of 998mm or shorter and the second one an inside diameter of l mm or larger and a length of 850mm or shorter.
Table 2 below identifies the SteriTite Sealed Containers with disposable filter, which may be sterilized in Amsco V-PRO 1 Plus and Amsco V-PRO Max low temperature Sterilization System:
| Part<br>Number | Description | Amsco V-PRO<br>1 Plus w/<br>polypropylene<br>disposable filter | Amsco V-PRO<br>maX w/<br>polypropylene<br>disposable filter | Maximum load<br>(lbs) inclusive of<br>sealed container<br>weight |
|----------------|-------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------|
| SC03MG | 3" high Endo mini-size w/ perforated base | X | X | 5.63 |
| SC03QG | 3" high Endo mid-size w/ perforated base | X | X | 8.85 |
| SC04FG | 4" high Full-size w/ perforated base | X | X | 19.97 |
| SC04HG | 4" high Half-size w/ perforated base | X | X | 9.90 |
| SC04QG | 4" high Mid-size w/ perforated base | X | X | 15.70 |
| SC06FG | 6" high Full-size w/ perforated base | X | X | 19.97 |
| SC06HG | 6" high Half-size w/ perforated base | X | X | 13.16 |
| SC06QG | 6" high Mid-size w/ perforated base | X | X | 19.97 |
| SC08FG | 8" high Full-size w/ perforated base | X | X | 19.97 |
| SC08HG | 8" high Half-size w/ perforated base | X | X | 15.92 |
| SC08QG | 8" high Mid-size w/ perforated base | X | X | 19.97 |
| SC05WG | 5" high Extra Wide w/ perforated base | X | X | 19.97 |
9
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Note: All containers for Amsco V-PRO 1, V-PRO 1 Plus AND V-PRO maX low temperature Sterilization System are perforated bottom containers, which must be used with single-use nonwoven Polypro filter.
| MEDITRAY PRODUCT | Amsco V-PRO 1 Plus | Amsco V-PRO maX |
|-------------------|--------------------|-----------------|
| Baskets | X | X |
| Trays | X | X |
| Insert Boxes | X | X |
| Metal Brackets | X | X |
| Metal Partitions | X | X |
| Posts | X | X |
| Silicone Brackets | X | X |
| Racks | X | X |
| Stringers | X | X |
# Table 3. MediTray Products Compatibility Table
### Table 4. SteriTite Accessories Compatibility
| SteriTite Accessories | Amsco V-PRO 1 Plus | Amsco V-PRO maX |
|-----------------------------|--------------------|-----------------|
| SCF02 Round filter | X | X |
| SCFM02 Rectangular filter | X | X |
| SCS01W Tamper Evident Seals | X | X |
| SCLH2O23 Load Card Large | X | X |
| SCLH2O24 Load Card Small | X | X |
#### Technological Characteristics (compared to the predicate(s)): 5.4
The SteriTite universal container system for Amsco V-PRO 1Plus and V-PRO Max, in Nonlumen and Flexible Cycle is the same SteriTite container previously cleared for steam, STERRAD 100, 100S, 200, NX, as well as EtO, Ozone and Hydrogen Peroxide (Amsco V-PRO1 ) Sterilization. Case Medical's SteriTite universal container and MediTray products are compatible with Amsco V-PRO 1Plus and V-PRO Max, in Non-lumen and Flexible Cycle. All containers are of equivalent sizes, have gasketed lids with latching mechanism and offer tamper evident features and external indicator as predicate devices. The SteriTite sealed container in this submission is the same container previously cleared.
#### ર્સ્ડ Performance Data:
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" was completed. The SteriTite universal container system with MediTray products were fully validated for Amsco V-PRO 1Plus in Lumen and Non Lumen and V-PRO Max, in Lumen, Non-Lumen and Flexible Cycle. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available AAMI standards.
#### ર્ડ Conclusion:
All data presented demonstrate Substantial Equivalence to the predicate devices.
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Image /page/4/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract caduceus or a series of flowing lines.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 4 2012
Ms. Tania Lupu Quality Assurance, QC Director Case Medical, Incorporated 19 Empire Blvd. South Hackensack, New Jersey 07606
Re: K112904
Trade/Device Name: SteriTite® Universal Container System & MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 5, 2012 Received: January 6, 2012
Dear Ms. Lupu:
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 approvisions of the Act. 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.
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# Page 2 – Ms. Lupu
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Semarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for Anthony Jubelson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
### Enclosure
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K112 904
# Indications for Use
510(k) Number (if known):
Device Name: SteriTite Universal Container System and MediTray products
### Indications for Use:
The SteriTite Universal Container System, with MediTray products, is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads.
- 30 days of real time shelf-life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle.
- Reuse testing: Material Compatibility was assessed after 100 cycles of AMSCO V-PRO 1 lumen ● cycles.
SteriTite Universal Container System is recommended for use in:
V-PRO 1 Plus sterilizer in: 1.
- Non-lumen cycles to sterilize non-luments, including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of ● forceps and scissors, and medical devices, including rigid endoscopes, with a single stainless steel lumen, with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
- 2. V-PRO maX sterilizer in:
- Non-lumen cycles to sterilize non-luments including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
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- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of . forceps and scissors, and medical devices, including rigid endoscopes with a single stainless steel lumen with an inside diameter of 3mm or larger, and a length of 400mm or shorter for a maximum of 20 lumens per load.
- Flexible cvcles to sterilize single or dual lumen surgical flexible endoscopes in either of two load . configurations (per sterilizer manufacturer instruction):
- Two flexible endoscopes and no additional load, each having either: a.
- a single lumen with an inside diameter of 1mm or larger, and a length of . 1050mm or shorter, or
- two lumens, with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter, and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
- One flexible endoscope and load, each having either: b.
- a single lumen with an inside diameter of 1mm or larger and a length of . 1050mm or shorter, or
- two lumens with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
The SteriTite Universal Container System is recommended to be used for the sterilization of surfaces and rigid or flexible lumens:
| | Table 1: SteriTite Universal Container System in AMSCO V-PRO sterilization. | | | | |
|--|-----------------------------------------------------------------------------|--|--|--|--|
|--|-----------------------------------------------------------------------------|--|--|--|--|
| Sterilizer | Cycle | Rigid lumens 3mm<br>dia. or larger and<br>400 mm long or<br>shorter | Flexible lumens 1 mm<br>dia. or larger and<br>1050mm long or<br>shorter | Surfaces |
|-----------------------|-----------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|----------|
| Amsco V-PRO<br>1 Plus | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| Amsco V-PRO<br>Max | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| | Flexible cycle | | X | |
Note:
Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.
Non-Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.
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2
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Table 2 below identifies the SteriTite Universal Sealed Containers with disposable filters, which may be sterilized in Amsco V-PRO 1 Plus, and Amsco V-PRO Max low temperature Sterilization System:
| Part<br>Number | Description | Amsco V-<br>PRO 1 Plus w/<br>polypropylene<br>disposable<br>filter | Amsco V-<br>PRO maX w/<br>polypropylene<br>disposable<br>filter | Maximum load<br>(lbs) inclusive<br>of sealed<br>container<br>weight |
|----------------|-------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------|
| SC02MG | 2" high Endo mini-size w/ perforated base | X | X | 5.63 |
| SC03MG | 3" high Endo mini-size w/ perforated base | X | X | 5.63 |
| SC02NG | 2" high Endo mid-size w/ perforated base | X | X | 8.85 |
| SC03NG | 3" high Endo mid-size w/ perforated base | X | X | 8.85 |
| SC04HG | 4" high Half-size w/ perforated base | X | X | 9.90 |
| SC06HG | 6" high Half-size w/ perforated base | X | X | 12.05 |
| SC08HG | 8" high Half-size w/ perforated base | X | X | 15.92 |
| SC04QG | 4" high Mid-size w/ perforated base | X | X | 15.70 |
| SC06QG | 6" high Mid-size w/ perforated base | X | X | 16.35 |
| SC08QG | 8" high Mid-size w/ perforated base | X | X | 19.97 |
| SC04FG | 4" high Full-size w/ perforated base | X | X | 19.97 |
| SC06FG | 6" high Full-size w/ perforated base | X | X | 19.97 |
| SC08FG | 8" high Full-size w/ perforated base | X | X | 19.97 |
| SC05WG | 5" high Extra Wide w/ perforated base | X | X | 19.97 |
All containers for Amsco V-PRO 1 Plus and V-PRO maX low temperature Sterilization System Note: are perforated bottom containers, which must be used with single-use non-woven Polypro filter.
Table 3. MediTray Products Compatibility Table
| MEDITRAY PRODUCT | Amsco V-PRO 1 Plus | Amsco V-PRO maX |
|-------------------|--------------------|-----------------|
| Baskets | X | X |
| Trays | X | X |
| Insert Boxes | X | X |
| Metal Brackets | X | X |
| Metal Partitions | X | X |
| Posts | X | X |
| Silicone Brackets | X | X |
| Racks | X | X |
| Stringers | X | X |
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3
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### Table 4. SteriTite Accessories Compatibility
| SteriTite Accessories | Amsco V-PRO 1 Plus | Amsco V-PRO maX |
|--------------------------------|--------------------|-----------------|
| SCF02 Round filter | X | X |
| SCFM02 Rectangular filter | X | X |
| SCS01W Tamper Evident<br>Seals | X | X |
| SCLH2O23 Load Card Large | X | X |
| SCLH2O24 Load Card Small | X | X |
Internal Stacking:
In Steris V-PRO 1 Plus, and V-PRO maX Non Lumen and Flexible Cycles, up to two (2) layers of baskets with insert box or four (4) layers of trays with insert box may be stacked within the SteriTite Universal Container System.
MediTray case/trays and insert boxes with lid and base are designed to contain items and are not meant to be stacked one on top of the other.
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Eshart F. Vausie-Wills
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112904
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