FDA Device Establishments · JSON-LD · Markdown
FEI 3003764610 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3003764610 |
|---|---|
| Owner / Operator | OSSUR Americas (#9026971) |
| Address | GRJOTHALS 5, REYKJAVIK, 110, IS |
| Mandatory US Agent | Ossur |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ILH |
| Regulation § (21 CFR) | 890.3475 |
| Proprietary names | Formfit Wrist; Formfit Wrist & Forearm; Formfit Pediatric Wrist Universal; Formfit Wrist and Forearm Universal; Formfit Pediatric Thumb Spica; Formfit Thumb OA Night; Formfit Thumb OA Day; Wrist Brace; Formfit Pro Wrist; Formfit Universal Thumb |
Source: openFDA. Public-domain (CC0).