VS3 Endoscope 4mm, Short, 0°, Wide FOV 153-0003

GUDID 18130400103052

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

• Primary Device ID: 18130400103052
• NIH Device Record Key: 39a8342d-dbee-4718-8081-41060bf95e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VS3 Endoscope 4mm, Short, 0°, Wide FOV
• Version Model Number: VS3-NE
• Catalog Number: 153-0003
• 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	18130400103052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123467
• Premarket Notification: K131434

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

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

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[18130400103052]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

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

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• 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