VS3 Iridium

GUDID 10884521815926

VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)

VISIONSENSE LTD.

Endoscope video camera

• Primary Device ID: 10884521815926
• NIH Device Record Key: f1f61e8e-7b8b-4751-867b-6a17cde93333
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium
• Version Model Number: 175-0051
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521815926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223020

FDA Product Code

• OWN: Confocal optical imaging

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: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [VS3 Iridium]

• 10813040013261: VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV - Refurbished
• 10813040013254: VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View - Refurbished
• 10813040013858: VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View
• 10813040013636: VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV
• 10884521844698: VS3 Iridium - Laser Light Source, 785nm (LLS)
• 10884521844681: VS3 Iridium - Miniature Microscope, 785nm (MMS-IR)
• 10884521815926: VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)