Anesthesiology
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- MiscellaneousMiscellaneous
- LEMHuman Lyophilized Dura Mater2Product Code
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief3Product Code
- LHYElectrode, Stabilized Epidural Spinal3Product Code
- LIIMonitor, Intracranial Pressure, Implanted3Product Code
- LKWLaser, Neurosurgical3Product Code
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease3Product Code
- LLFLaser, Neurosurgical, Argon3Product Code
- LLPLaser For Pain Therapy3Product Code
- LMEMonitor, Blood-Flow, Cerebral, Thermal Diffusion3Product Code
- LQDRecorder, Attention Task PerformanceUProduct Code
- LYIStimulator, Subcortical, Implanted For Epilepsy3Product Code
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy3Product Code
- MBXStimulator, Thalamic, Epilepsy, Implanted3Product Code
- BWKStimulator, Electro-AcupunctureUProduct Code
- KGFAdhesive, Tissue For Aneurysmorrhaphy3Product Code
- QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits2Product Code
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations3Product Code
- LBKDevice, Neurosurgical Fragmentation And AspirationUProduct Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- MFEAgent, Injectable, Embolic3Product Code
- MFRStimulator, Brain, Implanted, For Behavior ModificationFProduct Code
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor3Product Code
- MHZStimulator, Vestibular Acceleration, Therapeutic3Product Code
- MKDStimulator, Functional Walking Neuromuscular, Non-Invasive3Product Code
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)3Product Code
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)FProduct Code
- MUZStimulator, Autonomic Nerve, Implanted (Depression)3Product Code
- MVVDevice, AcupressureUProduct Code
- MXMCap, Cooling (Infants)3Product Code
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms3Product Code
- NJEIntracranial Neurovascular StentFProduct Code
- NPEMaterial, Embolization, Neurovascular, Polymerizing Or Precipitating3Product Code
- NQRSealant, Dural3Product Code
- NZKStimulator, Low Electric Field, Tumor Treatment3Product Code
- OBAPolymerizing, Neurovascular Embolization MaterialFProduct Code
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)FProduct Code
- OPRIntrasaccular Flow Disruption Device3Product Code
- OUTIntracranial Aneurysm Flow Diverter3Product Code
- OUUPolymeric Neurovascular EmbolizationFProduct Code
- OVCHeadframeNProduct Code
- OZJInhibitor, Postoperative Fibrosis (Adhesion Barrier)NProduct Code
- PAXSurgical KitFProduct Code
- PCQInhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)NProduct Code
- PFNImplanted Brain Stimulator For Epilepsy3Product Code
- PJSStimulator, Electrical, Implanted, For Essential Tremor3Product Code
- PMPDorsal Root Ganglion Stimulator For Pain Relief3Product Code
- POHMr-Guided Focused Ultrasound System3Product Code
- QCAIntracranial Coil-Assist Stent3Product Code
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief3Product Code
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy3Product Code
- QSLBrain Temperature Measurement System2Product Code
- QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms2Product Code
- QWDStimulator, Nerve, For Restless Legs Syndrome2Product Code
- QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation DeviceFProduct Code
- QWTPrognostic Assessment Software Of Mild Cognitive Impairment2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
- Page Type
- Product Code
- Definition
- The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.
- Physical State
- The gel is a sterile, absorbable, isotonic combination of sodium carboxymethylcellulose (CMC) and polyethylene oxide (PEO) with calcium chloride and sodium chloride in sterile water for injection.
- Technical Method
- The product is applied to coat the surgically traumatized tissue and surrounding area. The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process. The material is absorbed. It does not require a second operation for removal.
- Target Area
- The product is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues.
- Review Panel
- Neurology
- Submission Type
- Contact ODE
- Device Classification
- N
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
As product code OZJ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.