Home GUDID 20705036015878 N/A
Primary DI 20705036015878
Brand N/A
Company ETHICON ENDO-SURGERY, LLC
Model CRX18
Catalog number CRX18
Device description Colorectal Open Left Hemicolectomy/LAR Kit
Published 2018-01-18
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 20705036015878 Primary GS1 0 10705036015871 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705036015878 20705036015878 10705036015871 10705036015871
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.
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#