FDA device listing
REGENTOX SURGICAL GAUZE/ SPONGE
FDA device listing 1595870441 · MB Regentox Vietnam Trading Service Company Limited
Key facts
| Proprietary names | REGENTOX SURGICAL GAUZE/ SPONGE |
|---|---|
| Owner/operator | MB Regentox Vietnam Trading Service Company Limited |
| Owner/operator number | 10074869 |
| 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 | MB REGENTOX VIETNAM TRADING SERVICE COMPANY LIMITED |
| Establishment registrations | 3017041963 |
| FEI numbers | 3017041963 |
| Establishment operations | Foreign Private Label Distributor |
| 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