FDA device listing
SIROS Delivery Dome,SIR-Spheres Delivery Box
FDA device listing 1496239358 · Sirtex Medical Inc.
Key facts
| Proprietary names | SIROS Delivery Dome,SIR-Spheres Delivery Box |
|---|---|
| Owner/operator | Sirtex Medical Inc. |
| Owner/operator number | 9047689 |
| Product codes | KPY |
| Device names | KPY - Shield, Protective, Personnel |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.6500 |
| Review panels | Radiology |
| Registered establishments | Sirtex Germany Manufacturing GmbH, SIRTEX MEDICAL INC., Sirtex Singapore Manufacturing Pte Ltd, Sirtex Wilmington LLC |
| Establishment registrations | 3005579300, 3009088444, 3012690638, 3013070673 |
| FEI numbers | 3005579300, 3009088444, 3012690638, 3013070673 |
| Establishment operations | Complaint File Establishment, Specification Developer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database