OZJ — Inhibitor, Postoperative Fibrosis (Adhesion Barrier) Class N

FDA Device Classification

FDA product code OZJ covers "Inhibitor, Postoperative Fibrosis (Adhesion Barrier)", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
OZJ
Device Class
Class N
Regulation Number
Submission Type
Review Panel
NE
Medical Specialty
Unknown
Implant
No

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.