FDA Device Establishments · JSON-LD · Markdown
FEI 3031914485 · Manufacture Medical Device · Status: Active
| FEI Number | 3031914485 |
|---|---|
| Owner / Operator | Precision AI Pty Ltd (#10091281) |
| Address | Suite 18, 36 Agnes Street, Fortitude Valley, Brisbane Queensland, 4006, AU |
| Mandatory US Agent | Encore Medical |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | KWS, PHX, QHE |
| Regulation § (21 CFR) | 888.3660 |
| Proprietary names | Precision AI Surgical Planning System (PAI-SPS) |
Source: openFDA. Public-domain (CC0).