Home GUDID 00630094200422 Bioseal Inc.
Primary DI 00630094200422
Brand Bioseal Inc.
Company BIOSEAL
Model 2004B/50
Device description Assorted Sponge Set
Published 2023-12-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 10630094200429 Package GS1 50 In Commercial Distribution 00630094200422 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10630094200429 10630094200429 00630094200422 00630094200422 630094200422 0630094200422
GMDN Terms# Term, Definition table Term Definition General-purpose surgical sponge A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.
Regulatory Flags# DUNS number 186968939 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label 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 20192253050339 Curity Cardinal Health 200, LLC GDY 2023-03-27 20192253050346 Curity Cardinal Health 200, LLC GDY 2023-03-27 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