FDA Device Establishments · JSON-LD · Markdown
FEI 3031160994 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3031160994 |
|---|---|
| Owner / Operator | Elutia Inc. (#10055257) |
| Address | 20 Firstfield Rd, Gaithersburg, MD, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DXZ |
| Regulation § (21 CFR) | 870.3470 |
| Proprietary names | ECM for Carotid Repair; VasCure for Carotid Repair |
Source: openFDA. Public-domain (CC0).