FDA device listing
RENASYS F LARGE W/SOFT PORT,RENASYS F LARGE W/SOFT PORT INT,RENASYS F MEDIUM W/SOFT PORT,RENASYS F MEDIUM W/SOFT PORT…
FDA device listing 1541998019 · MIDWEST STERILIZATION CORP.
Key facts
| Proprietary names | RENASYS F LARGE W/SOFT PORT,RENASYS F LARGE W/SOFT PORT INT,RENASYS F MEDIUM W/SOFT PORT,RENASYS F MEDIUM W/SOFT PORT INT,RENASYS F SMALL W/SOFT PORT,RENASYS F SMALL W/SOFT PORT INT,Renasys Gauze Sterile Dressing Kit w softport,RENASYS G STERILE W/SOFT PORT US,RENASYS SOFT PORT,RENASYS SOFT PORT STAND ALONE INT |
|---|---|
| Owner/operator | MIDWEST STERILIZATION CORP. |
| Owner/operator number | 1928237 |
| Product codes | OMP |
| Device names | OMP - Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4780 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MIDWEST STERILIZATION CORP. |
| Establishment registrations | 1928237 |
| FEI numbers | 1928237 |
| Establishment operations | Contract Sterilizer |
| 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