FDA device listing
Enema Catheter
FDA device listing 1359334260 · Sotera Health LLC
Key facts
| Proprietary names | Enema Catheter |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FCE |
| Device names | FCE - Enema Kit |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5210 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics EO Canada, Inc., Sterigenics Shanghai ETO Ltd., Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1061124, 9611665, 3004111573, 3007007790 |
| FEI numbers | 1000512168, 3002807095, 3004111573, 3007007790 |
| 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