FDA device listing
Battery-Powered Instruments Charged Through Sterile Barriers
FDA device listing 1315160215 · Global Resources (Vietnam) Group Limited Company
Key facts
| Owner/operator | Global Resources (Vietnam) Group Limited Company |
|---|---|
| Owner/operator number | 10058607 |
| Product codes | SAM |
| Device names | SAM - Battery-Powered Instruments Charged Through Sterile Barriers |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | GLOBAL RESOURCES (VIETNAM) GROUP LIMITED COMPANY |
| Establishment registrations | 3014925393 |
| FEI numbers | 3014925393 |
| Establishment operations | 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