Home GUDID 05055270971593 Rocket
Primary DI 05055270971593
Brand Rocket
Company ROCKET MEDICAL PLC
Model R57525-00-ES
Catalog number R57525-00-ES
Device description Rocket DIsposable Needle Guide
Published 2016-09-07
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 05055270971586 Package GS1 10 In Commercial Distribution 05055270971593 Package GS1 6 In Commercial Distribution 05055270971579 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05055270971586 05055270971586 5055270971586 05055270971593 05055270971593 5055270971593 05055270971579 05055270971579 5055270971579
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Lumen/Inner Diameter 1.651 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# 
rocketmedical.com