FDA device listing
9891 Curi-Strip 1/4"X1-1/2",9892 Curi-Strip 1/4" x 3",9894 Curi-Strip 1/2"X 4",DKC71153 Shur Strip Wound Closure Strip…
FDA device listing 1358732969 · GENTELL
Key facts
| Proprietary names | 9891 Curi-Strip 1/4"X1-1/2",9892 Curi-Strip 1/4" x 3",9894 Curi-Strip 1/2"X 4",DKC71153 Shur Strip Wound Closure Strip 1/2" x 4 " Non-Sterile,DKC81118 Shur Strip Wound Closure Strip 1/4" x 3" Sterile,DKC81119 Shur Strip Wound Closure Strip 1/4" x 1 -1/2 " Sterile,DKC81120 Shur Strip Wound Closure Strip 1/4" x 4" Sterile,DKC81121 Shur Strip Wound Closure Strip 1/2" x 4" Sterile,TP1100-WOUND CLOSURE… |
|---|---|
| Owner/operator | GENTELL |
| Owner/operator number | 10026501 |
| Premarket submissions | K894205 |
| Product codes | FPX |
| Device names | FPX - Strip, Adhesive, Closure, Skin |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.), DERMA SCIENCES NANTONG INCORPORATION |
| Establishment registrations | 9680091, 3003636207 |
| FEI numbers | 3002806830, 3003636207 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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