FDA device listing
S40 Sterilant Concentrate (MM-MF, CM-SD),SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD),SYSTEM 1…
FDA device listing 1912387486 · STERIS Corporation
Key facts
| Proprietary names | S40 Sterilant Concentrate (MM-MF, CM-SD),SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD),SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD),SYSTEM 1 endo Quick Connects (HP-MF, CM-SD),SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD),SYSTEM 1E Quick Connects (HP-MF, CM-SD),SYSTEM 1E Trays and Containers (QB-MF, CM-SD) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Premarket submissions | K251666 |
| Product codes | MED |
| Device names | MED - Sterilant, Medical Devices |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6885 |
| Review panels | General Hospital |
| Registered establishments | STERIS Canada ULC, STERIS Corporation, STERIS CORPORATION |
| Establishment registrations | 1527821, 9680353, 3000251274, 3003950207 |
| FEI numbers | 1527821, 3000251274, 3003950207, 3004097451 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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