Home GUDID 20884521700762 Situate
Primary DI 20884521700762
Brand Situate
Company Covidien LP
Model G0202-08P01C-1
Catalog number G0202-08P01C-1
Device description Gauze - RF and X-ray Detectable USP Type VII, 8 Ply
Published 2019-02-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 20884521700762 Package GS1 2000 In Commercial Distribution 10884521700765 Primary GS1 0 30884521700769 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521700762 20884521700762 10884521700765 10884521700765 30884521700769 30884521700769
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 Device Size Text, specify 0 Length 2 Inch Width 2 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0.5 KiloPascal 1.06 KiloPascal Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -22 Degrees Fahrenheit 140 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 Keep dry; Storage Environment Atmospheric Pressure 0.7 KiloPascal 1.06 KiloPascal Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit
Regulatory Flags# DUNS number 058614483 Device count 10 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 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
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