FDA device listing
1 Level General Purpose Rack (CM53) (QB-MF),2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE),2 Level…
FDA device listing 1774095284 · STERIS Corporation
Key facts
| Proprietary names | 1 Level General Purpose Rack (CM53) (QB-MF),2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE),2 Level Manifold Rack (FD74800) (QB-MF),2 Level Manifold Rack with Equal Level Space (FD79100) (QB-MF),2 Level Manifold Rack with Equal Level Space - Large (FD81000) (QB-MF),3 Level base Rack for MIS, Ophtalmic or dental application (FD024) (QB-MF),3 Level Manifold Rack 444 (FD70S600) (QB-MF),3… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | MEC |
| Device names | MEC - Disinfector, Medical Devices |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6992 |
| Review panels | General Hospital |
| Registered establishments | ALBERT BROWNE LTD., MEDISAFE UK LTD., STERIS Canada ULC |
| Establishment registrations | 8021896, 9617134, 9680353 |
| FEI numbers | 3000255542, 3001168737, 3004097451 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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