Dermapac, Inc. 5011
Dermapac, Inc. 5011 is a Class I device made by Dermapac Inc., listed in FDA GUDID since 12 Sep 2022 (UDI-DI 10810102270266), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10810102270266 | Date12 Sep 2022 | StatusListed |
Official records
- AccessGUDID record 10810102270266
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Dermapac, Inc.
- Generic name
- Radiopaque woven surgical sponge
- Model / reference
- 5011
- Primary DI / UDI-DI
- 10810102270266
- FDA product code
- GDY
- GMDN term
- Radiopaque woven surgical sponge
- Device class
- Class I
- Regulation number
- 878.4450
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GDY (Gauze/Sponge, Internal, X-Ray Detectable).
- STERILE GAUZE SPONGES X-RAY DETECTABLE by Team Mfg., Inc.
- OREX by Thantex Specialties, Inc.
- ULTRACELL SUCTION SPONGE by Ultracell Medical Technologies, Inc.
- LAP SPONGE by Carapace, Inc.
- LAPORATOMY SPONGES SIZES:18X18, 12X12, 4X18, 8X36 by Elof Hansson, Inc.
- STANFORD STERILE LAP SPONGES by Lukens Corp.
- Expanding ear tampon 66420 by Spiggle & Theis Medizintechnik GmbH
- GAUZE SPONGES by Clinical Resources, Inc.
- 0206711000 0206-711-000 by Stryker Corp.
- ROSEBUD DISSECTOR by Lorrex Health Products