VorOtek L Scope VSLH-2.5 M

GUDID 09348227000108

VorOtek L Scope - HeadBand 2.5X Magnification Loupes @ 42cm working distance with Fully Integrated Surgical Quality Dimmable LED Illumination. Adjustable IPD. Includes Power Pack, Charger & Carry Case.

VOROTEK PTY LTD

Surgical binoculars, reusable

• Primary Device ID: 09348227000108
• NIH Device Record Key: 545e57a3-67a5-45d1-bb85-49f25bad58c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VorOtek L Scope
• Version Model Number: VSLH-2.5 M
• Catalog Number: VSLH-2.5 M
• 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	09348227000108 [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 L Scope]

• 09348227000122: VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 47cm working distance with Fully Integr
• 09348227000139: VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 42cm working distance with Fully Integr
• 09348227000108: VorOtek L Scope - HeadBand 2.5X Magnification Loupes @ 42cm working distance with Fully Integrat
• 09348227000092: VorOtek L Scope - HeadBand. 2.5X Magnification Loupes @ 47cm working distance with Fully Integra