G-EYE Colonoscope 40-550

GUDID 07290018671108

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 for endoscopy 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 positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.

SMART MEDICAL SYSTEMS LTD

Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope Flexible fibreoptic colonoscope

• Primary Device ID: 07290018671108
• NIH Device Record Key: 5db7df1a-0f85-4965-b2b4-242019227d62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-EYE Colonoscope
• Version Model Number: G-EYEQ180I
• Catalog Number: 40-550
• Company DUNS: 649905544
• Company Name: SMART MEDICAL SYSTEMS LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com
• Phone: +97297444321
• Email: info@smartmedsys.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -47 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018671108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192588

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-09
• Device Publish Date: 2020-12-01

On-Brand Devices [G-EYE Colonoscope]

• 07290018671153: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671146: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671139: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671122: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671115: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671108: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671092: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671085: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671078: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671061: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671054: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671047: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671030: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671023: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671016: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671009: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671283: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671276: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671269: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671252: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671245: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671238: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671221: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh
• 07290018671214: The G-EYE® colonoscope is intended to be used with a compatible video processor (including ligh