FDA device listing
STANPAD(STANPAD 0401, STANPAD 1001, STANPAD 1010, STANPAD 7538, STANPAD 81001, STANPAD 81010, STANPAD…
FDA device listing 1587216848 · MANTIZ Co.,Ltd.
Key facts
| Proprietary names | STANPAD(STANPAD 0401, STANPAD 1001, STANPAD 1010, STANPAD 7538, STANPAD 81001, STANPAD 81010, STANPAD 80505),STANPAD(STANPAD P1040, STANPAD 51010, STANPAD 10505, STANPAD 75300) |
|---|---|
| Owner/operator | MANTIZ Co.,Ltd. |
| Owner/operator number | 10083878 |
| 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 | MANTIZ Co.,Ltd. |
| Establishment registrations | 3021389253 |
| FEI numbers | 3021389253 |
| Establishment operations | Complaint File Establishment, 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