FDA device listing
Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN,Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle…
FDA device listing 1878890894 · STERIS Corporation
Key facts
| Proprietary names | Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN,Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec,Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi,Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STERIS AST CZ s.r.o., STERIS Schweiz AG, STERIS SPA, Synergy Health Ede BV, Synergy Health Marseille SAS, Synergy Health Radeberg GMBH, Synergy Health Sterilisation UK Ltd, Synergy Health Westport Ltd, Synergy Sterilisation (M) Sdn Bhd |
| Establishment registrations | 8043792, 3002806603, 3002807310, 3004784537, 3008102042, 3009756327, 3010162973, 3010173425, 3010220595 |
| FEI numbers | 3002806603, 3002807036, 3002807038, 3002807041, 3002807310, 3002808269, 3002924544, 3004784537, 3010220595 |
| 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