Home GUDID 20705036015694 N/A
Primary DI 20705036015694
Brand N/A
Company ETHICON ENDO-SURGERY, LLC
Model CRX11
Catalog number CRX11
Device description Colorectal Laparoscopic Left Hemicolectomy/LAR Kit
Published 2017-06-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20705036015694 Primary GS1 0 10705036015697 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705036015694 20705036015694 10705036015697 10705036015697
GMDN Terms# Term, Definition table Term Definition General/plastic surgical procedure kit, non-medicated, single-use A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -22 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 044606982 Device count 4 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 
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