FDA device listing
General Convenience Kit,General Purpose Kit,General Surgery Tray (Kit),Hand Pack,Hip Pack,Knee Pack,SurgiTrack,Toe Nail…
FDA device listing 1176147396 · O & M Halyard, Inc.
Key facts
| Proprietary names | General Convenience Kit,General Purpose Kit,General Surgery Tray (Kit),Hand Pack,Hip Pack,Knee Pack,SurgiTrack,Toe Nail Kit |
|---|---|
| Owner/operator | O & M Halyard, Inc. |
| Owner/operator number | 10039033 |
| Product codes | LRO |
| Device names | LRO - General Surgery Tray |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ArcRoyal uc, AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305, MEDICAL ACTION INDUSTRIES, INC. 306, OWENS & MINOR DISTRIBUTION INC.OM05, OWENS & MINOR DISTRIBUTION INC. OM30, Owens & Minor Distribution Inc. OM41, Owens & Minor Distribution Inc. OM44, Owens & Minor Distribution Inc. OM45, OWENS & MINOR DISTRIBUTION INC. OM65, OWENS & MINOR DISTRIBUTION INC. OM87 |
| Establishment registrations | 1030451, 1047429, 1823410, 1000124971, 2000028362, 3002669946, 3003924117, 3010376936, 3011144486, 3036002406 |
| FEI numbers | 1030451, 1047429, 1823410, 1000124971, 2000028362, 3002669946, 3003924117, 3010376936, 3011144486, 3036002406 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 10–99 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