FDA device listing
Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD),Celerity 20 STEAM Biological Indicator (LCB063) (PC-UMXD),Celerity…
FDA device listing 1352691298 · STERIS Corporation
Key facts
| Proprietary names | Browne Spiral Load Check (AB123) (FP-USXMD, HP-USXMD),Celerity 20 STEAM Biological Indicator (LCB063) (PC-UMXD),Celerity 20 STEAM Process Challenge Device for Dynamic Air Removal Cycles (LCB064, LCB065) (PC-UMXD) |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | FRC |
| Device names | FRC - Indicator, Biological Sterilization Process |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2800 |
| Review panels | General Hospital |
| Registered establishments | STERIS Corporation, STERIS CORPORATION |
| Establishment registrations | 3000251274, 3004080920, 3007412809 |
| FEI numbers | 3000251274, 3004080920, 3007412809 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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