FDA device listing
Antibacterial Gel Wound Dressing
FDA device listing 1167997794 · WINNER MEDICAL CO., LTD.
Key facts
| Proprietary names | Antibacterial Gel Wound Dressing |
|---|---|
| Owner/operator | WINNER MEDICAL CO., LTD. |
| Owner/operator number | 9012349 |
| Premarket submissions | K231057 |
| Product codes | FRO |
| Device names | FRO - Dressing, Wound, Drug |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO |
| Review panels | General & Plastic Surgery |
| Registered establishments | WINNER MEDICAL CO., LTD., Winner Medical (Jiayu) Co., Ltd. |
| Establishment registrations | 3008132238, 3030067857, 3036978602 |
| FEI numbers | 3008132238, 3030067857, 3036978602 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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