Home GUDID 10630094110056 Bioseal Inc.
Primary DI 10630094110056
Brand Bioseal Inc.
Company BIOSEAL
Model 11005/50
Device description Peanut Sponges in Holder
Published 2023-06-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 10630094110056 Package GS1 50 In Commercial Distribution 00630094110059 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 10630094110056 10630094110056 00630094110059 00630094110059 630094110059 0630094110059
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 HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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