FDA device listing
COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM,Coloplast Fistula Bed Drainage Bag,Coloplast Flexible Lid
FDA device listing 1221578967 · Coloplast Corp.
Key facts
| Proprietary names | COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM,Coloplast Fistula Bed Drainage Bag,Coloplast Flexible Lid |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Product codes | FON |
| Device names | FON - Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | COLOPLAST A/S, Coloplast Hungary, KFT, COLOPLAST HUNGARY KFT |
| Establishment registrations | 9610694, 3003814961, 3008262278 |
| FEI numbers | 3002806731, 3003814961, 3008262278 |
| Establishment operations | 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