FDA device listing
Deluxe Patient Pack,Standard Patient Pack
FDA device listing 1013895716 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | Deluxe Patient Pack,Standard Patient Pack |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| 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 | Beaver-Visitec International, Inc., Grupo American Industries, S.A. de C.V |
| Establishment registrations | 1211998, 3013421458, 3013466775 |
| FEI numbers | 1211998, 3013421458, 3013466775 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer, 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