Home GUDID 07290018671139
G-EYE Colonoscope
Primary DI 07290018671139
Brand G-EYE Colonoscope
Company SMART MEDICAL SYSTEMS LTD
Model G-EYE3890Li
Catalog number 40-538
Device description The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning.
Published 2020-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Product Codes# Code, Name table Code Name FDF Colonoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290018671139 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290018671139 07290018671139 7290018671139
GMDN Terms# Term, Definition table Term Definition Flexible fibreoptic colonoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -47 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 649905544 Device count 1 DM exempt true Serial number true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-06-18 06973786293260 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-09 06973786293284 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-09 06973786293307 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-09 06973786293321 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-09 06973786293222 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-04 06973786293246 Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) FDF 2026-06-04 07290016992113 Aer-O-Scope Disposable Colonoscope G.I. VIEW LTD FDF 2026-05-27 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664927465 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15