FDA device listing
TheraGenesis Meshed Bilayer Wound Matrix
FDA device listing 1393671745 · GUNZE MEDICAL LIMITED
Key facts
| Proprietary names | TheraGenesis Meshed Bilayer Wound Matrix |
|---|---|
| Owner/operator | GUNZE MEDICAL LIMITED |
| Owner/operator number | 10088147 |
| Premarket submissions | K213498 |
| Product codes | KGN |
| Device names | KGN - Wound Dressing With Animal-Derived Material(S) |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.KGN |
| Review panels | General & Plastic Surgery |
| Registered establishments | GUNZE MEDICAL LIMITED |
| Establishment registrations | 3027419979 |
| FEI numbers | 3027419979 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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