FDA device listing
DUP9322- Gazetex gauze bandage roll 4.5 in X 4.1 yards,GEN-15310 Gentell Conforming Stretch Gauze 3" x 75",GEN- 15450…
FDA device listing 1720085320 · GENTELL
Key facts
| Proprietary names | DUP9322- Gazetex gauze bandage roll 4.5 in X 4.1 yards,GEN-15310 Gentell Conforming Stretch Gauze 3" x 75",GEN- 15450 Gentell Rolled Gauze Bandage 4.5 x 4.1 YDS |
|---|---|
| Owner/operator | GENTELL |
| Owner/operator number | 10026501 |
| Product codes | NAB |
| Device names | NAB - Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4014 |
| Review panels | General & Plastic Surgery |
| Registered establishments | DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.), DERMA SCIENCES NANTONG INCORPORATION, GENTELL |
| Establishment registrations | 2530957, 9680091, 3003636207 |
| FEI numbers | 1000522686, 3002806830, 3003636207 |
| Establishment operations | Manufacturer, Repackager/Relabeler, 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