FDA device listing
ConvaTec Loop Ostomy Rod,ESTEEM SYNERGY Professional Kit,ESTEEM synergy Professional Kit - Loop Ostomy…
FDA device listing 1980085316 · ConvaTec
Key facts
| Proprietary names | ConvaTec Loop Ostomy Rod,ESTEEM SYNERGY Professional Kit,ESTEEM synergy Professional Kit - Loop Ostomy System,GentleTouch Loop Ostomy Systems - Post Operative Kits,Loop Ostomy Kits,Loop Ostomy Rod,NATURA Stomahesive Post Operative Surgical Ostomy System,NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod,SUR-FIT Loop Ostomy Rod |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Premarket submissions | K811240 |
| Product codes | EXB, EZP |
| Device names | EXB - Collector, Ostomy, EZP - Rod, Colostomy |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 876.4270, 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., CONVATEC LIMITED, ConvaTec Limited, GDC Building |
| Establishment registrations | 9618003, 1000317571, 3008806809, 3011987967 |
| FEI numbers | 1000317571, 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
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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