Home GUDID 05055270943132 Rocket
Primary DI 05055270943132
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57490
Catalog number R57490
Device description Rocket Cervix Adaptor Small - 27mm
Published 2017-01-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx false
OTC false
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270921734 Package GS1 10 In Commercial Distribution 05055270943132 Package GS1 2 In Commercial Distribution 05055270900340 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270921734 05055270921734 5055270921734 05055270943132 05055270943132 5055270943132 05055270900340 05055270900340 5055270900340
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 Outer Diameter 27 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 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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