Saneso

GUDID G347SAN1GA0

Saneso Single Camera Gastroscope with high definition imaging, 140-160 degree FOV, lens wash system, dedicated tissue wash system, LED lighting, select band imaging, a vertical & horizontal bending radius of 180 & 160 degrees.

Saneso Inc.

Flexible video gastroscope, reusable

• Primary Device ID: G347SAN1GA0
• NIH Device Record Key: 3f1aa0f0-bdf6-4485-b744-041d7b79795b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saneso
• Version Model Number: SAN1G-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
• 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: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter
• Length: 1040 Millimeter
• Outer Diameter: 11.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G347SAN1GA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210052

FDA Product Code

• FDS: Gastroscope 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: 2022-11-21
• Device Publish Date: 2022-11-11

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