VorOtek M Scope VSMH

GUDID 09348227000153

VorOtek M Scope - HeadBand. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case.

VOROTEK PTY LTD

Surgical binoculars, reusable

• Primary Device ID: 09348227000153
• NIH Device Record Key: 03a3028f-808b-4370-8452-406032badc6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VorOtek M Scope
• Version Model Number: VSMH
• Catalog Number: VSMH
• 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	09348227000153 [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: 2023-08-16
• Device Publish Date: 2023-08-08

On-Brand Devices [VorOtek M Scope]

• 09348227000160: VorOtek M Scope - SpecFrame. Plate Magnification with Fully Integrated Surgical Quality Dimmable
• 09348227000153: VorOtek M Scope - HeadBand. Plate Magnification with Fully Integrated Surgical Quality Dimmable