Home GUDID 05055270936165
Rocket
Primary DI 05055270936165
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57710-SX-70
Catalog number R57710-SX-70
Device description Rocket SX D/L Aspiration Needle
Published 2016-09-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05055270936165 Package GS1 10 In Commercial Distribution 05055270957566 Package GS1 20 In Commercial Distribution 05055270914774 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270936165 05055270936165 5055270936165 05055270957566 05055270957566 5055270957566 05055270914774 05055270914774 5055270914774
GMDN Terms# Term, Definition table Term Definition IVF oocyte aspiration needle, single-use A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 32 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 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#