FDA device listing
Disposable Surgical Mask (sterile, non-sterile); Medical Protective Mask (sterile, non-sterile),Protection Plus Lab Coat
FDA device listing 1548708116 · SAFETY-MED PRODUCTS, INC.
Key facts
| Proprietary names | Disposable Surgical Mask (sterile, non-sterile); Medical Protective Mask (sterile, non-sterile),Protection Plus Lab Coat |
|---|---|
| Owner/operator | SAFETY-MED PRODUCTS, INC. |
| Owner/operator number | 9067562 |
| Product codes | LYU |
| Device names | LYU - Accessory, Surgical Apparel |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SAFETY-MED PRODUCTS, INC. |
| Establishment registrations | 3004962765 |
| FEI numbers | 3004962765 |
| Establishment operations | 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