VS3 Iridium - Visionsense 3DHD & IR Fluorescence V 143-0011

GUDID 18130400103458

VISIONSENSE LTD.

Endoscope video camera Endoscope video camera Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system

• Primary Device ID: 18130400103458
• NIH Device Record Key: 8c0e3232-80b6-4423-838e-e9997fcdc717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium - Visionsense 3DHD & IR Fluorescence V
• Version Model Number: VS3-IR
• Catalog Number: 143-0011
• 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	18130400103458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150018
• 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by VISIONSENSE LTD.

• 10884521842489 - VS3 Visionsense Camera Control Unit (CCU): 2023-03-21
• 10813040013636 - VS3 Iridium: 2022-07-13 VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV
• 10813040013858 - VS3 Iridium: 2022-07-13 VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View
• 10884521833173 - VS3 Visionsense Camera Control Unit (CCU): 2022-05-18
• 10884521834644 - VS3 Iridium - Laser Light Source (LLS): 2022-05-17
• 10884521834651 - VS3 Iridium - Laser Light Source, 785nm (LLS): 2022-05-17
• 10813040013988 - VS3 Iridium - Fluorescence High Definition Camera (Camera-IR): 2021-08-18
• 10813040013995 - VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR): 2021-08-18