FDA Device Establishments · JSON-LD · Markdown
FEI 3012690638 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3012690638 |
|---|---|
| Owner / Operator | Sirtex Medical Inc. (#9047689) |
| Address | 300 Unicorn Park Dr., 2nd Fl.,, Woburn, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IWJ |
| Regulation § (21 CFR) | 892.5650 |
| Proprietary names | SIR-Spheres Delivery Set; SIR-Spheres V-Vial; V-Vial; SIROS Delivery Set; SIR-Spheres Accessories Pack |
Source: openFDA. Public-domain (CC0).