FDA device listing
Kirwan2512 (CH1.NR) - Disposable Bipolar Irrigating Cord,Kirwan2512 (CH1.NR) - Disposable Irrigation Bipolar Cord…
FDA device listing 1028116681 · STERIS Corporation
Key facts
| Proprietary names | Kirwan2512 (CH1.NR) - Disposable Bipolar Irrigating Cord,Kirwan2512 (CH1.NR) - Disposable Irrigation Bipolar Cord Assembly |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1220477, 1319660 |
| FEI numbers | 1220477, 1000136478 |
| 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