VS3 Iridium - Fluorescence High Definition Camera (Camera-IR) 174-0051

GUDID 10813040013988

VISIONSENSE LTD.

Endoscope video camera

• Primary Device ID: 10813040013988
• NIH Device Record Key: 3b246c4b-082e-4e7a-be55-3985cd4d439d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium - Fluorescence High Definition Camera (Camera-IR)
• Version Model Number: VS3-IR
• Catalog Number: 174-0051
• 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	10813040013988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150018
• Premarket Notification: K152204

FDA Product Code

• HRX: Arthroscope
• OWN: Confocal Optical Imaging

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

[10813040013988]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-18
• Device Publish Date: 2021-08-10

Devices Manufactured by VISIONSENSE LTD.

• 10884521815926 - VS3 Iridium: 2024-11-19 VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)
• 10884521816695 - VS3-IR: 2024-11-19 153-0054 VS3 IR ENDOSCOPE 5MM 30DEG
• 10884521816701 - VS3-IR: 2024-11-19 153-0055 VS3 IR ENDOSCOPE 5MM 0DEG
• 10884521816718 - VS3-IR: 2024-11-19 153-0074 VS3 IR ENDOSCOPE 10MM 30DEG
• 10884521816725 - VS3-IR: 2024-11-19 153-0075 VS3 IR ENDOSCOPE 10MM 0DEG
• 10884521821187 - VS3-NE: 2024-11-19 VS3 Visionsense Camera Control Unit (CCU)
• 10884521844681 - VS3 Iridium: 2024-11-19 VS3 Iridium - Miniature Microscope, 785nm (MMS-IR)
• 10884521844698 - VS3 Iridium: 2024-11-19 VS3 Iridium - Laser Light Source, 785nm (LLS)