VorOtek O Scope VSOH-3D

GUDID 09348227001938

VorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.

VOROTEK PTY LTD

Surgical binoculars, reusable

• Primary Device ID: 09348227001938
• NIH Device Record Key: 65d82267-ad87-4bf9-8f7f-250e98d7ee8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VorOtek O Scope
• Version Model Number: VSOH-3D
• Catalog Number: VSOH-3D
• Company DUNS: 744332997
• Company Name: VOROTEK PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	09348227001938 [Primary]

FDA Product Code

• HJH: Loupe, Binocular, Low Power

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: 2023-08-17
• Device Publish Date: 2023-08-09

On-Brand Devices [VorOtek O Scope]

• 09348227002089: VorOtek O Scope - SpecFrame - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumin
• 09348227001938: VorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumina
• 09348227000023: VorOtek O Scope - HeadBand - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumina
• 09348227000016: VorOtek O Scope - SpecFrame - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumin