FDA device listing
Skin barrier film spray,Skin barrier film wand,Sting Free Skin Barrier Wipe
FDA device listing 1873670713 · WINNER MEDICAL CO., LTD.
Key facts
| Proprietary names | Skin barrier film spray,Skin barrier film wand,Sting Free Skin Barrier Wipe |
|---|---|
| Owner/operator | WINNER MEDICAL CO., LTD. |
| Owner/operator number | 9012349 |
| Product codes | NEC |
| Device names | NEC - Bandage, Liquid, Skin Protectant |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5090 |
| Review panels | General Hospital |
| Registered establishments | WINNER MEDICAL CO., LTD., Winner Medical (Jiayu) Co., Ltd., Winner Medical (Wuhan) Co., Ltd. |
| Establishment registrations | 3008132238, 3030067857, 3031180770, 3036978602 |
| FEI numbers | 3008132238, 3030067857, 3031180770, 3036978602 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, 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