FDA device listing
PRIMAGARD,PRIMASOFT
FDA device listing 1748673416 · PRIMED Medical Products Inc.
Key facts
| Proprietary names | PRIMAGARD,PRIMASOFT |
|---|---|
| Owner/operator | PRIMED Medical Products Inc. |
| Owner/operator number | 9030179 |
| Premarket submissions | K081633 |
| Product codes | FXX |
| Device names | FXX - Mask, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | PRIMED Laos Medical Products Manufacturing Sole Co., Ltd., PRIMED LIYANG MEDICAL PRODUCTS MANUFACTURING CO., LTD., PRIMED MEDICAL PRODUCTS INC., PRIMED Medical Products Manufacturing Ltd. |
| Establishment registrations | 9615270, 3005599545, 3017229009, 3020755815 |
| FEI numbers | 3002750002, 3005599545, 3017229009, 3020755815 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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