FDA device listing
GraftGuide,GraftGuide Mano,GraftGuide Micro,Kerecis Omega3 Burn,Kerecis Omega3 GraftGuide,Kerecis Omega3…
FDA device listing 1749320705 · Kerecis ehf
Key facts
| Proprietary names | GraftGuide,GraftGuide Mano,GraftGuide Micro,Kerecis Omega3 Burn,Kerecis Omega3 GraftGuide,Kerecis Omega3 MicroGraft,Kerecis Omega3 OR,Kerecis Omega3 SurgiClose,Kerecis Omega3 SurgiClose Micro,Mano,MariGen Wound Extra,SurgiClose,SurgiClose Micro |
|---|---|
| Owner/operator | Kerecis ehf |
| Owner/operator number | 10045392 |
| Premarket submissions | K190528 |
| 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 | KERECIS EHF |
| Establishment registrations | 3010600625, 3016429246 |
| FEI numbers | 3010600625, 3016429246 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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