ColonPRO™ 4.0 CPRO401-US

GUDID 78055060110344

Software to be used in GI Genius™ systems.

LINKVERSE SRL

Endoscopic video image interpretive software

• Primary Device ID: 78055060110344
• NIH Device Record Key: 686a804a-fda5-414b-9db5-9172778ef789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColonPRO™ 4.0
• Version Model Number: 4.0.1
• Catalog Number: CPRO401-US
• Company DUNS: 338806666
• Company Name: LINKVERSE SRL
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055060110345 [Primary]
GS1	78055060110344 [Package]; Contains: 08055060110345; Package: Box of 7 USB drives [7 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241887

FDA Product Code

• QNP: Gastrointesinal Lesion Software Detection System

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: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [ColonPRO™ 4.0]

• 78055060110290: CPRO40.US
• 78055060110344: Software to be used in GI Genius™ systems.