FDA device listing
BIOBRANE Dressing,BIOBRANE Glove
FDA device listing 1073055971 · SMITH AND NEPHEW MEDICAL LTD.
Key facts
| Proprietary names | BIOBRANE Dressing,BIOBRANE Glove |
|---|---|
| Owner/operator | SMITH AND NEPHEW MEDICAL LTD. |
| Owner/operator number | 9001952 |
| Premarket submissions | K242146 |
| Product codes | FRO, KGN |
| Device names | FRO - Dressing, Wound, Drug, KGN - Wound Dressing With Animal-Derived Material(S) |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO, ORCA1.KGN |
| Review panels | General & Plastic Surgery |
| Registered establishments | Smith & Nephew Medical Ltd |
| Establishment registrations | 8043484 |
| FEI numbers | 3002808194 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database