FDA Device Establishments · JSON-LD · Markdown
FEI 3004051158 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3004051158 |
|---|---|
| Owner / Operator | SCIENCE & BIO MATERIALS (#9063735) |
| Address | ZI DU MONGE, LOURDES Hautes-Pyrenees, 65100, FR |
| Mandatory US Agent | Dawa Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HXX |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | ComposiTCP Modular Driver, Catalog Number 110004607; LIGAFIX green screwdriver for 7 & 8 mm screws, Catalog Number LIG9008046; ComposiTCP Modular Driver, Catalog Number 905274; LIGAFIX blue screwdriver for 9, 10 & 11 mm screws, Catalog Number LIG9009017; ecoFIX diameter 5.5-6.5 mm Screwdriver, Catalog Number EPA9000403; OTIS-C-PLUS diam. 3.5 mm hexagonal screwdriver, Catalog Number EVO9069436; FIXIT Knotless / ecoFIX Knotless Screwdriver, Catalog Number EPA9000315; Screwdriver for OTIS screw extraction, Catalog Number EVO9069439; ecoFIX diameter 4.5 mm Screwdriver, Catalog Number EPA9000401; LIGAFIX ratchet screwdriver rod Diameter 9-10-11 mm, Catalog Number LIG9000311 |
Source: openFDA. Public-domain (CC0).