Home GUDID 10705036015086 N/A
Primary DI 10705036015086
Brand N/A
Company ETHICON ENDO-SURGERY, LLC
Model BX03
Catalog number BX03
Device description Bariatric Kit Laparoscopic Sleeve Gastrectomy
Published 2016-08-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20705036015083 Package GS1 4 In Commercial Distribution 10705036015086 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705036015083 20705036015083 10705036015086 10705036015086
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 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# 
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