FDA device listing
Burn Dressing,Chitosan Hemostiatic Gauze,dry prep sponge stick,Kaolin Hemostatic Gauze,Medical Gauze Sponge
FDA device listing 1426199222 · Heaven Healthcare Co., Ltd.
Key facts
| Proprietary names | Burn Dressing,Chitosan Hemostiatic Gauze,dry prep sponge stick,Kaolin Hemostatic Gauze,Medical Gauze Sponge |
|---|---|
| Owner/operator | Heaven Healthcare Co., Ltd. |
| Owner/operator number | 10050953 |
| Product codes | NAB |
| Device names | NAB - Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4014 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Heaven Healthcare Co., Ltd. |
| Establishment registrations | 3012034017 |
| FEI numbers | 3012034017 |
| Establishment operations | Manufacturer |
| 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