FDA device listing
ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE),AMSCO 600 STEAM Sterilizer (MY-MF),RAS 12 Long Rack…
FDA device listing 1618118842 · STERIS Corporation
Key facts
| Proprietary names | ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE),AMSCO 600 STEAM Sterilizer (MY-MF),RAS 12 Long Rack (FD257) (QB-MF),RAS 12 Rack (FD256) (QB-MF),RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (QB-MF),V-PRO 60 Low Temperature Sterilization System (MY-CFE),V-PRO maX 2 Low Temperature Sterilization System (MY-MF),V-PRO s2 Low Temperature Sterilization System… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Premarket submissions | K222849 |
| Product codes | FLE, MLR, NVE, PEC |
| Device names | FLE - Sterilizer, Steam, MLR - Sterilizer, Chemical, NVE - Washer, Cleaner, Automated, Endoscope, PEC - Sterilizer Automated Loading System |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 880.6860, 880.6880 |
| Review panels | Gastroenterology & Urology, General Hospital |
| Registered establishments | STERIS Canada ULC, STERIS MEXICO, S. de R.L. de C.V. |
| Establishment registrations | 9680353, 3005899764 |
| FEI numbers | 3004097451, 3005899764 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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