Home GUDID 00821925038295 Gyrus ACMI
Primary DI 00821925038295
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model CB-365
Device description Cleaning Brush To Be Used In Any Endoscope With a 3 Fr (1 mm) Channel 3 Fr, 65 CM (2/PK)
Published 2018-09-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925008762 Package GS1 2 In Commercial Distribution 00821925038295 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00821925008762 00821925008762 821925008762 0821925008762 00821925038295 00821925038295 821925038295 0821925038295
GMDN Terms# Term, Definition table Term Definition Endoscope cleaning brush access adaptor A small device intended to be attached to an endoscope port to allow controlled introduction of a cleaning brush (not included) into the channels of the endoscope; it is not intended for use during a medical procedure. It typically has a tubular form with one or more lumens. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821925019157 VOCOM 143000 2015-10-24 00821925019164 GYRUS ACMI, INC 143001 2015-10-24 00821925019171 GYRUS ACMI, INC 143002 2015-10-24 00821925019225 GYRUS ACMI, INC 143006 2015-10-24 00821925019232 GYRUS ACMI, INC 143007 2015-10-24 00821925019249 GYRUS ACMI, INC 143008 2015-10-24 00821925019300 GYRUS ACMI, INC 143003 2015-10-24 00821925019317 GYRUS ACMI, INC 143004 2015-10-24 00821925019324 GYRUS ACMI, INC 143005 2015-10-24 00821925012738 EVONOS GMBH & Co. Kg 130015 2018-09-04 00821925012783 EVONOS 130020 2018-09-06 00821925012790 EVONOS 130021-ENT 2018-09-06 00821925012806 EVONOS 130022 2018-09-06 00821925012813 EVONOS 130023 2018-09-06 00821925012820 EVONOS 130024 2018-09-06 00821925012837 Gyrus ACMI 130025-ENT 2018-09-06 00821925012929 EVONOS 130038 2018-09-06 00821925013001 EVONOS 130201 2018-09-10 00821925013018 EVONOS 130202 2018-09-10 00821925013025 EVONOS 130203 2018-09-10
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