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U.S. Department of Health and Human Services

Product Classification

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Device inhibitor, postoperative fibrosis (adhesion barrier)
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
Product CodeOZJ
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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