FDA device listing
Skin prep tray
FDA device listing 1962775829 · SunMed Group Holdings, LLC dba AirLife
Key facts
| Proprietary names | Skin prep tray |
|---|---|
| Owner/operator | SunMed Group Holdings, LLC dba AirLife |
| Owner/operator number | 10044795 |
| Product codes | OJU |
| Device names | OJU - Skin Prep Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., SunMed Group Holdings, LLC |
| Establishment registrations | 1314417, 8030673 |
| FEI numbers | 1314417, 3004213967 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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