FDA device listing
Fiducial Holder,Grid Immobilization Plate LBS C-C,Grid Immobilization Plate LBS M-L,Grid Mobilization Plate,Needle Block…
FDA device listing 1427250316 · Sotera Health LLC
Key facts
| Proprietary names | Fiducial Holder,Grid Immobilization Plate LBS C-C,Grid Immobilization Plate LBS M-L,Grid Mobilization Plate,Needle Block Holder,Needle Hub Assembly,Pillar Immobilization Plate,Pillar Immobilization Plate BBC,Pillar Immobilization Plate LBS C-C,Pillar Immobilization Plate LBS M-L |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | MOS |
| Device names | MOS - Coil, Magnetic Resonance, Specialty |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1000 |
| Review panels | Radiology |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC |
| Establishment registrations | 1054811, 2029275 |
| FEI numbers | 1000114185, 1000306431 |
| Establishment operations | Contract Sterilizer |
| 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