FDA Device Establishments · JSON-LD · Markdown
FEI 3003865243 · Manufacture Medical Device · Status: Active
| FEI Number | 3003865243 |
|---|---|
| Owner / Operator | BON ROUX (PTY) LTD (#9050392) |
| Address | 695 TETRA AVENUE, MORELETAPARK, PRETORIA Gauteng, 0044, ZA |
| Mandatory US Agent | Mainspring Medical LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LKY |
| Regulation § (21 CFR) | 876.5020 |
| Proprietary names | OTC - VACURECT Vacuum Constriction Device (RE: K020969); RX - VACURECT Vacuum Constriction Device (RE: K032776) |
Source: openFDA. Public-domain (CC0).