VS3 Iridium Fluorescence Vision System 805 110V- INS configuration 143-0041

GUDID 10884521810143

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 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: 10884521810143
• NIH Device Record Key: 0fc0b858-83f5-497f-b8df-5f622a53ffd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Iridium Fluorescence Vision System 805 110V- INS configuration
• Version Model Number: VS3-IR
• Catalog Number: 143-0041
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521810143 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01

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