VS3 Iridium - Light Integrator (Beamcombiner) 161-0001

GUDID 10884521817555

VISIONSENSE LTD.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor Light source adaptor

• Primary Device ID: 10884521817555
• NIH Device Record Key: 8110e6bd-30cc-44af-91db-8e64d829cf7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium - Light Integrator (Beamcombiner)
• Version Model Number: VS3-IR
• Catalog Number: 161-0001
• 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	10884521817555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152204

FDA Product Code

• GWG: Endoscope, Neurological
• 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: 2021-03-29
• Device Publish Date: 2021-03-21

On-Brand Devices [VS3 Iridium - Light Integrator (Beamcombiner)]

• 18130400103625: VS3-IR
• 10884521817555: VS3-IR