Home GUDID 05055270943125
Rocket
Primary DI 05055270943125
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57412
Catalog number R57412
Device description Rocket URIGLOW Transilluminating Stents
Published 2016-09-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270943125 Package GS1 40 In Commercial Distribution 05055270900333 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270943125 05055270943125 5055270943125 05055270900333 05055270900333 5055270900333
GMDN Terms# Term, Definition table Term Definition Ureteral transilluminator, single-use A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for (trans)illumination to facilitate visualization of the ureter. It is used to aid dissection during laparoscopic and/or open abdominal surgery; sometimes it is referred to as illuminating catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 40 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 Premarket exempt false 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#