Home GUDID 05055270964205 Rocket
Primary DI 05055270964205
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57036
Catalog number R57036
Device description Rocket AmniocentesIs & CVS Sampling Set
Published 2017-01-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270964205 Package GS1 10 In Commercial Distribution 05055270964212 Package GS1 8 In Commercial Distribution 05055270964199 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270964205 05055270964205 5055270964205 05055270964212 05055270964212 5055270964212 05055270964199 05055270964199 5055270964199
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 Outer Diameter 1.473 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 101 KiloPascal 101 KiloPascal
Regulatory Flags# DUNS number 544313588 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label true 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# 
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