Saneso

GUDID G347SAN360CA0

Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle lens wash system, dedicated tissue wash system, LED lighting, select band and dual band imaging, vertical & horizontal bending radius of 180 degrees & 160 degrees, preserved mechanical characteristics, and a continuous guide view™ of the lumen.

Saneso Inc.

Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable

• Primary Device ID: G347SAN360CA0
• NIH Device Record Key: 633b968f-95e4-4ffa-80c7-a0a9f674a321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saneso
• Version Model Number: SAN360C-A
• Company DUNS: 117059270
• Company Name: Saneso Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com
• Phone: 6812984613
• Email: koushik.garapati@saneso.com

Device Dimensions

• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter
• Length: 1680 Millimeter
• Outer Diameter: 15.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G347SAN360CA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210052

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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [Saneso]

• G347SAN360GA0: Saneso Gastroscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle len
• G347SAN360CA0: Saneso Colonoscope 360A. Five cameras with integrated 360 degree field of view, multi-nozzle len
• G347SBA0: The Saneso Box incorporates state of the art electronics and software and is the brain behind Sa
• G347SAN1GA0: Saneso Single Camera Gastroscope with high definition imaging, 140-160 degree FOV, lens wash sys
• G347SAN1CA0: Single Camera Colonoscope with high definition imaging,140-160 degree FOV, lens wash system, ded