Home GUDID 05055270913722 Rocket
Primary DI 05055270913722
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57422-00-ST
Catalog number R57422-00-ST
Device description Rocket 5Fg HSG Sonohystogram Catheter
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270935113 Package GS1 10 In Commercial Distribution 05055270956514 Package GS1 20 In Commercial Distribution 05055270913722 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270935113 05055270935113 5055270935113 05055270956514 05055270956514 5055270956514 05055270913722 05055270913722 5055270913722
GMDN Terms# Term, Definition table Term Definition Intrauterine imaging medium catheter A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 5 French Length 30 Centimeter
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 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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