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.
| Device Type ID | 3861 |
| Device Name | Inhibitor, Postoperative Fibrosis (adhesion Barrier) |
| 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 |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3861 |
| Device | Inhibitor, Postoperative Fibrosis (adhesion Barrier) |
| Product Code | OZJ |