FDA Device Establishments · JSON-LD · Markdown
FEI 3000190635 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3000190635 |
|---|---|
| Owner / Operator | AME INT'L. (#9036247) |
| Address | 7440 SOUTH WEST 50 TERR., No. 108, MIAMI, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HTW |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | Cannulated Headed Reamer; 2.8mm, 3mm, 3.2mm, 4mm Reusable Drill Bits; 2.8mm, 3mm, 3.2mm, 4mm Unsterile Drill Bits; 2.8mm, 3mm, 3.2mm, 4mm Sterile Drill Bits; Cannulated Drill |
Source: openFDA. Public-domain (CC0).