FDA device listing
MM0048 Gentell Manuka Honey Wound Dressing 20g (formerly MANUKApli 20g),MM0049 Gentell Manuka Honey Wound Dressing 15g…
FDA device listing 1099984419 · GENTELL
Key facts
| Proprietary names | MM0048 Gentell Manuka Honey Wound Dressing 20g (formerly MANUKApli 20g),MM0049 Gentell Manuka Honey Wound Dressing 15g (formerly MANUKApli 15g),MM0051 Gentell Manuka Honey Wound Dressing 44g (formerly MANUKApli 44g) |
|---|---|
| Owner/operator | GENTELL |
| Owner/operator number | 10026501 |
| Premarket submissions | K092689 |
| Product codes | FRO |
| Device names | FRO - Dressing, Wound, Drug |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO |
| Review panels | General & Plastic Surgery |
| Registered establishments | GENTELL |
| Establishment registrations | 2530957 |
| FEI numbers | 1000522686 |
| Establishment operations | Repackager/Relabeler |
| 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