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U.S. Department of Health and Human Services

Product Classification

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Device inhibitor, postoperative fibrosis (spine adhesion barrier)
Definition Intended for use as a mechanical barrier to adhesion formation.
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. A syringe and applicator are provided to deliver the gel.
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 Neural tissues in the spine.
Review Panel Physical Medicine
Product CodePCQ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Rehabilitation Devices Branch (PMDB)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible