FDA device listing
420-DK16 COLOSTOMY CORSET (16CM) (S-XXL),420-DK26 COLOSTOMY CORSET (26CM) (S-XXL),420-K COLOSTOMY CORSET,423 UMBILICAL…
FDA device listing 1198553195 · VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA
Key facts
| Proprietary names | 420-DK16 COLOSTOMY CORSET (16CM) (S-XXL),420-DK26 COLOSTOMY CORSET (26CM) (S-XXL),420-K COLOSTOMY CORSET,423 UMBILICAL HERNIA CORSET (Sizes S - XXL);,429-C INGUINAL TRUSS (DOUBLE SIDED),429 INGUINAL TRUSS (SINGLE SIDED) |
|---|---|
| Owner/operator | VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SA |
| Owner/operator number | 10091542 |
| Product codes | EXN |
| Device names | EXN - Support, Hernia |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5970 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SANAYI VE TICARET LTD STI |
| Establishment registrations | 3033436414 |
| FEI numbers | 3033436414 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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