FDA device listing
Endoscopic Sponge,Internal X-Ray Gauze,Lap Sponge,Specialty Sponge,Vaginal Sponge
FDA device listing 1801276660 · O & M Halyard, Inc.
Key facts
| Proprietary names | Endoscopic Sponge,Internal X-Ray Gauze,Lap Sponge,Specialty Sponge,Vaginal Sponge |
|---|---|
| Owner/operator | O & M Halyard, Inc. |
| Owner/operator number | 10039033 |
| Product codes | GDY |
| Device names | GDY - Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4450 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDICAL ACTION INDUSTRIES, INC. 306 |
| Establishment registrations | 1030451 |
| FEI numbers | 1030451 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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