FDA device listing
DYNACOR URETHRAL CATHETER TRAY; MEDLINE UROLOGICAL KIT W/STERILE, WATER FILL,MEDLINE STERILE 100% SILICONE FOLEY…
FDA device listing 1050973910 · MIDWEST STERILIZATION CORP.
Key facts
| Proprietary names | DYNACOR URETHRAL CATHETER TRAY; MEDLINE UROLOGICAL KIT W/STERILE, WATER FILL,MEDLINE STERILE 100% SILICONE FOLEY CATHETER; MEDLINE STERILE CLOSED SYSTEM; DYNACOR STERILE CARELON SILICON CATHETER; |
|---|---|
| Owner/operator | MIDWEST STERILIZATION CORP. |
| Owner/operator number | 1928237 |
| Product codes | KOD |
| Device names | KOD - Catheter, Urological |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | MIDWEST STERILIZATION CORP. |
| Establishment registrations | 1928237, 3005012805 |
| FEI numbers | 1928237, 3005012805 |
| 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