ColonPRO™ 4.0

GUDID 78055060110290

LINKVERSE SRL

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• Primary Device ID: 78055060110290
• NIH Device Record Key: 1c016cbe-3e81-42a3-9ffa-7d5f68fb786c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColonPRO™ 4.0
• Version Model Number: CPRO40.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	08055060110291 [Primary]
GS1	78055060110290 [Package]; Contains: 08055060110291; Package: Box of 7 USB drives [7 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233964

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: 2024-03-05
• Device Publish Date: 2024-02-26

Devices Manufactured by LINKVERSE SRL

• 78055060110290 - ColonPRO™ 4.0: 2024-03-05
• 78055060110290 - ColonPRO™ 4.0: 2024-03-05
• 08055060110314 - GI Genius™ Module 100: 2024-03-05
• 08055060110321 - GI Genius™ Module 200: 2024-03-05
• 08055060110178 - USB K-switch: 2023-08-21
• 08055060110185 - Footswitch: 2023-08-21