FDA device listing
AmericanCatheter5917 (SP) - American Catheter,Merit1383 (TM) - Cen-Step Centesis Catheter,Merit1383 (TM) - ReSolve…
FDA device listing 1649419997 · STERIS Corporation
Key facts
| Proprietary names | AmericanCatheter5917 (SP) - American Catheter,Merit1383 (TM) - Cen-Step Centesis Catheter,Merit1383 (TM) - ReSolve Locking Drainage Catheter |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | GBX |
| Device names | GBX - Catheter, Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations Inc, Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1047843, 1450662, 1526711, 1643817, 2030624, 3009888344 |
| FEI numbers | 1047843, 1450662, 1526711, 1643817, 3000206435, 3009888344 |
| 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