FDA device listing
ConvaTec™ Hydrocolloid Sealing Strips,DUOACTIVE,DUOACTIVE CGF,DUOACTIVE Extra Thin,DuoDERM,DuoDerm Border,DuoDERM…
FDA device listing 1897973508 · ConvaTec
Key facts
| Proprietary names | ConvaTec™ Hydrocolloid Sealing Strips,DUOACTIVE,DUOACTIVE CGF,DUOACTIVE Extra Thin,DuoDERM,DuoDerm Border,DuoDERM CGF,DuoDERM CGF Border,DuoDERM E,DuoDERM E Border,DuoDERM Extra Thin,DuoDERM Extra Thin CGF,DuoDERM Signal,DuoDERM Signal CGF,Foam Lite ConvaTec,GranuFlex,GranuFlex Border,GranuFlex Extra Thin,GranuFlex Signal,VariHesive CGF Border,VariHesive Extra Thin,VARIHESIVE Extra Thin,VariHesive… |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Product codes | NAD |
| Device names | NAD - Dressing, Wound, Occlusive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4020 |
| Review panels | General & Plastic Surgery |
| 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
- 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