Home GUDID 10818566010619 PremierPro
Primary DI 10818566010619
Brand PremierPro
Company SVS LLC
Model X8425
Catalog number X8425
Device description PremierPro Lap Sponge 12"x12" Sterile, 5/pk
Published 2020-08-25
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 10818566010619 Package GS1 40 In Commercial Distribution 00818566010612 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 10818566010619 10818566010619 00818566010612 00818566010612 818566010612 0818566010612
GMDN Terms# Term, Definition table Term Definition Radiopaque woven surgical sponge, sterile A non-medicated sterile 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.
Regulatory Flags# DUNS number 831375089 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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
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