Home GUDID 05055270921239 Rocket
Primary DI 05055270921239
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57035
Catalog number R57035
Device description Rocket AmniocentesIs Exchange Set
Published 2017-01-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270942623 Package GS1 10 In Commercial Distribution 05055270964021 Package GS1 2 In Commercial Distribution 05055270921239 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270942623 05055270942623 5055270942623 05055270964021 05055270964021 5055270964021 05055270921239 05055270921239 5055270921239
GMDN Terms# Term, Definition table Term Definition Chorionic villus sampling needle A slender, sharply-pointed metal tube intended for transabdominal chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorionic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. It is introduced transcutaneously into the uterus, possibly using a guide cannula and under ultrasonographic guidance, and may include connectors, tubing and aspiration syringe. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 17 Centimeter Outer Diameter 1.473 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 101 KiloPascal 101 KiloPascal Handling Environment Humidity 1 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Handling Environment Temperature -5 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 101 KiloPascal 101 KiloPascal Storage Environment Humidity 1 Percent (%) Relative Humidity 70 Percent (%) Relative Humidity Storage Environment Temperature -5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 544313588 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# 
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