FDA device listing
Silicone Scar Gel,Silicone Scar Gel Ultra,Silicone Scar Repair Sheet
FDA device listing 1544913945 · WINNER MEDICAL CO., LTD.
Key facts
| Proprietary names | Silicone Scar Gel,Silicone Scar Gel Ultra,Silicone Scar Repair Sheet |
|---|---|
| Owner/operator | WINNER MEDICAL CO., LTD. |
| Owner/operator number | 9012349 |
| Product codes | MDA |
| Device names | MDA - Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | WINNER MEDICAL CO., LTD., Winner Medical (Huanggang) Co., Ltd. |
| Establishment registrations | 3007966889, 3030067857 |
| FEI numbers | 3007966889, 3030067857 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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