Home GUDID 20192253049340 Dermacea
Primary DI 20192253049340
Brand Dermacea
Company Cardinal Health 200, LLC
Model 441606
Catalog number 441606
Device description Dermacea X-Ray Sponges
Published 2024-12-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name GDY Gauze/sponge, internal, x-ray detectable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50192253049341 Package GS1 48 In Commercial Distribution 20192253049340 Primary GS1 0 10192253049343 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50192253049341 50192253049341 20192253049340 20192253049340 10192253049343 10192253049343
GMDN Terms# Term, Definition table Term Definition Radiopaque woven surgical sponge A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 8 Inch Width 4 Inch
Regulatory Flags# DUNS number 961027315 Device count 10 Premarket exempt true Lot or batch true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10198956239692 CARDINAL HEALTH Cardinal Health 200, LLC GDY 2025-11-28 07613327465853 SurgiCount Safety-Sponge STRYKER CORPORATION GDY 2025-09-03 10080196717811 MEDLINE MEDLINE INDUSTRIES, INC. GDY 2025-04-25 10197106760994 CARDINAL HEALTH Cardinal Health 200, LLC GDY 2025-01-29 10080196031313 MEDLINE MEDLINE INDUSTRIES, INC. GDY 2025-01-16 10080196743926 MEDLINE MEDLINE INDUSTRIES, INC. GDY 2024-10-15 10326053119504 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119511 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119528 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119535 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119542 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119559 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119566 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119573 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 10326053119580 Regard™ Resource Optimization & Innovation, L.L.C. GDY 2023-08-09 08600036785272 USMEDCO US MEDCO INC GDY 2023-07-14 08600036785340 USMEDCO US MEDCO INC GDY 2023-07-14 08600036785418 USMEDCO US MEDCO INC GDY 2023-07-14 08600036785586 USMEDCO US MEDCO INC GDY 2023-07-14 08600036785654 USMEDCO US MEDCO INC GDY 2023-07-14 10197106046968 CARDINAL HEALTH Cardinal Health 200, LLC GDY 2023-07-12 10192253050288 Kerlix Cardinal Health 200, LLC GDY 2023-03-24 10665973000012 Dukal Dukal LLC GDY 2022-12-06 10665973000029 Dukal Dukal LLC GDY 2022-12-06 10665973000036 Dukal Dukal LLC GDY 2022-12-06 10665973000050 Dukal Dukal LLC GDY 2022-12-06 10665973000067 Dukal Dukal LLC GDY 2022-12-06 10665973000081 Dukal Dukal LLC GDY 2022-12-06 10665973000098 Dukal Dukal LLC GDY 2022-12-06 10665973000166 Dukal Dukal LLC GDY 2022-12-06