FDA Device Establishments · JSON-LD · Markdown
FEI 3009088444 · Repack or Relabel Medical Device · Status: Active
| FEI Number | 3009088444 |
|---|---|
| Owner / Operator | Sirtex Medical Inc. (#9047689) |
| Address | 50 Science Park Road, #01-01, Science Park II, Singapore Central Singapore, 117406, SG |
| Mandatory US Agent | Sirtex Medical Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KPY |
| Regulation § (21 CFR) | 892.6500 |
| Proprietary names | SIROS Delivery Dome; SIR-Spheres Delivery Box |
Source: openFDA. Public-domain (CC0).