FDA Device Establishments · JSON-LD · Markdown
FEI 3016429246 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3016429246 |
|---|---|
| Owner / Operator | Kerecis ehf (#10045392) |
| Address | Sundstraeti 38, Isafjordur Vestfiroir, 400, IS |
| Mandatory US Agent | Kerecis LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KGN |
| Proprietary names | MariGen Wound Extra; Kerecis Omega3 GraftGuide; Kerecis Omega3 OR; Kerecis Omega3 Burn; SurgiClose; SurgiClose Micro; Kerecis Omega3 SurgiClose Micro; Kerecis Omega3 MicroGraft; GraftGuide; Kerecis Omega3 SurgiClose |
Source: openFDA. Public-domain (CC0).