FDA device listing
HEMOCLIP,HEMOCLIP TI LG 10/CART 120/BOX,HEMOCLIP TI LG 15/CART 150/BOX,HEMOCLIP TI ML 10/CART 160/BOX,HEMOCLIP TI ML…
FDA device listing 1604591779 · Sotera Health LLC
Key facts
| Proprietary names | HEMOCLIP,HEMOCLIP TI LG 10/CART 120/BOX,HEMOCLIP TI LG 15/CART 150/BOX,HEMOCLIP TI ML 10/CART 160/BOX,HEMOCLIP TI ML 10/CART 200/BOX,HP TI LG 10/CART 120/BOX,HP TI LG 10/CART 120/BOX W/TAPE,HP TI ML 10/CART 120/BOX,HP TI ML 10/CART 120/BOX W/TAPE |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FZP |
| Device names | FZP - Clip, Implantable |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4300 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1018470 |
| FEI numbers | 1018470 |
| 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