FDA device listing
199-141 McKesson, Manuka Honey Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm),199-142 McKesson, Manuka Honey Super…
FDA device listing 1865830813 · Gentell
Key facts
| Proprietary names | 199-141 McKesson, Manuka Honey Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm),199-142 McKesson, Manuka Honey Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm),199-143 McKesson, Manuka Honey Lite Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm),199-144 McKesson, Manuka Honey Lite Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm),First Honey Adhesive Bandages,First Honey Adhesive… |
|---|---|
| Owner/operator | Gentell |
| Owner/operator number | 10039061 |
| Premarket submissions | K102659 |
| 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 | ManukaMed Limited Partnership |
| Establishment registrations | 3009348823 |
| FEI numbers | 3009348823 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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