FDA device listing
ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier,DuoLock Curved Tail Closure,SUR-FIT NATURA Disposable Convex…
FDA device listing 1372449025 · ConvaTec
Key facts
| Proprietary names | ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier,DuoLock Curved Tail Closure,SUR-FIT NATURA Disposable Convex Insert,SUR-FIT NATURA Flange Cap with Filter,SUR-FIT Plus Straight Tail Closures,Visi-FLow Irrigation Adapter Faceplate,Visi-Flow Irrigation Sleeve Tail Closure |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Product codes | EZS |
| Device names | EZS - Appliance, Colostomy, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., ConvaTec Limited, GDC Building |
| Establishment registrations | 9618003, 3008806809, 3011987967 |
| FEI numbers | 3003264198, 3008806809, 3011987967 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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