VS3 Visionsense Camera Control Unit (CCU) 443-0001

GUDID 10813040013377

VISIONSENSE LTD.

Endoscope video camera

• Primary Device ID: 10813040013377
• NIH Device Record Key: 0e03bb46-70fa-4272-a719-a505370a6e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Visionsense Camera Control Unit (CCU)
• Version Model Number: VS3-NE
• Catalog Number: 443-0001
• Company DUNS: 532199478
• Company Name: VISIONSENSE LTD.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10813040013377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131434

FDA Product Code

• HRX: Arthroscope

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: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [VS3 Visionsense Camera Control Unit (CCU)]

• 18130400103373: VS3-NE
• 10813040013377: VS3-NE
• 10813040013094: VS3-NE
• 10884521833173: VS3-NE
• 10884521842489: VS3-NE