FDA device listing
ACTIVE LIFE One-Piece Closed-End Pouch,EsteemBody Closed Pouch Ostomy System,ESTEEM+ Closed Pouch,ESTEEM+ Soft…
FDA device listing 1659894410 · ConvaTec
Key facts
| Proprietary names | ACTIVE LIFE One-Piece Closed-End Pouch,EsteemBody Closed Pouch Ostomy System,ESTEEM+ Closed Pouch,ESTEEM+ Soft CONVEX,ESTEEM Synergy+ Closed Pouch,LITTLE ONES SUR-FIT Plus Two-Piece Close End Pouch,LITTLE ONES Two-Piece Adhesive Coupling Technology,NATURA+ Closed Pouch,NATURA SUR-FIT Closed-End Mini Pouch,NATURA SUR-FIT Closed-End Pouch,NATURA SUR-FIT Closed-End Pouch with Filter,STOMADRESS… |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Product codes | EZQ |
| Device names | EZQ - Pouch, Colostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., CONVATEC LIMITED, ConvaTec Limited, GDC Building, UNOMEDICAL S.R.O. |
| Establishment registrations | 9618003, 1000317571, 3005778470, 3008806809, 3011987967 |
| FEI numbers | 1000317571, 3003264198, 3005778470, 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