FDA device listing
Smith&Nephew3754 (NR) - 4.5 Incisor,Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm,Smith&Nephew3754…
FDA device listing 1547130942 · STERIS Corporation
Key facts
| Proprietary names | Smith&Nephew3754 (NR) - 4.5 Incisor,Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm,Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite™ / Minitac™2.0,Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite™ 3.0,S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite™ 2.0,S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite™ 3.7,Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | HWE |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Isomedix Operations Inc, Isomedix Operations, Inc, Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1220477, 1424263, 1450662, 1526711, 1643817, 1720929, 2032098, 2183744, 3009888344 |
| FEI numbers | 1220477, 1450662, 1526711, 1643817, 1720929, 2183744, 3003015552, 3003058448, 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