FDA Device Establishments · JSON-LD · Markdown
FEI 3005325790 · Manufacture Medical Device · Status: Active
| FEI Number | 3005325790 |
|---|---|
| Owner / Operator | Elite Surgical Supplies (Pty) Ltd (#10025504) |
| Address | 54 De Havilland Crescent, Persequor Technopark, Persequor, Pretoria Gauteng, 0020, ZA |
| Mandatory US Agent | JALEX Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KWQ |
| Regulation § (21 CFR) | 888.3060 |
| Proprietary names | Biolign Rotoloc |
Source: openFDA. Public-domain (CC0).