Home GUDID 20705036015182 N/A
Primary DI 20705036015182
Brand N/A
Company ETHICON ENDO-SURGERY, LLC
Model BX13
Catalog number BX13
Device description Bariatric Kit Laparoscopic Gastric Bypass
Published 2016-08-07
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 20705036015182 Primary GS1 0 10705036015185 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705036015182 20705036015182 10705036015185 10705036015185
GMDN Terms# Term, Definition table Term Definition Laparoscopic surgical procedure kit, non-medicated, single-use A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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# 
eesus.jnj.com