CapsoCam Plus 2795

GUDID 00867770000261

Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit

CAPSOVISION, INC.

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• Primary Device ID: 00867770000261
• NIH Device Record Key: f7115e77-03cb-43be-9bc9-db8c6ab58a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CapsoCam Plus
• Version Model Number: SV-3KIT
• Catalog Number: 2795
• Company DUNS: 789635740
• Company Name: CAPSOVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com
• Phone: 408-624-1488
• Email: info@capsovision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867770000209 [Previous]
GS1	00867770000261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192662

FDA Product Code

• NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

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: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [CapsoCam Plus]

• 00867770000209: Small Bowel Capsule Endoscope
• 00867770000261: Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit