FDA device listing
Dermapose Refresh Stand,DIRECT2 Lid,DIRECT2 Lid, Drain Lever Replacement Kit,DIRECT2 Lid, Drain Port Replacement…
FDA device listing 1908758171 · Bimini Health Tech
Key facts
| Proprietary names | Dermapose Refresh Stand,DIRECT2 Lid,DIRECT2 Lid, Drain Lever Replacement Kit,DIRECT2 Lid, Drain Port Replacement Kit,Puregraft Combined Adapter,Puregraft Vacuum Lid,Vacuum Lid - O-Ring Kit,Vacuum Lid - Port Replacement Kit |
|---|---|
| Owner/operator | Bimini Health Tech |
| Owner/operator number | 10048045 |
| Product codes | MDM |
| Device names | MDM - Instrument, Manual, Surgical, General Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Bimini Health Tech |
| Establishment registrations | 3022978896 |
| FEI numbers | 3022978896 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, 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