FDA device listing
Back Table Covers,Equipment Covers,Halyard Gown,Surgical Drape,Surgical Drapes and/or accessories,Surgical Drapes and/or…
FDA device listing 1662622203 · O&M Halyard, Inc.
Key facts
| Proprietary names | Back Table Covers,Equipment Covers,Halyard Gown,Surgical Drape,Surgical Drapes and/or accessories,Surgical Drapes and/or accessories (Stockinette Drapes),Surgical Packs |
|---|---|
| Owner/operator | O&M Halyard, Inc. |
| Owner/operator number | 10057479 |
| Product codes | PUI |
| Device names | PUI - Drape, Surgical, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Honduras Kitting, S.A., La Ada de Acuna, La Ada De Acuna, S. de. R. L. de C. V., O&M Halyard, Inc. |
| Establishment registrations | 9616096, 3005997949, 3014421917, 3035642068 |
| FEI numbers | 3003807323, 3005997949, 3014421917, 3035642068 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer, Contract Manufacturer |
| 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