VorOtek X-Series Headlight VLHH-DA

GUDID 09348227001181

VorOtek X-Series HeadLight - HeadBand. Fully Portable Surgical Quality Dimmable LED Illumination with Adjustable Spot Size. Includes Power Pack, Charger & Carry Case.

VOROTEK PTY LTD

Head-worn lamp

• Primary Device ID: 09348227001181
• NIH Device Record Key: 5fba92db-adef-43dd-92a6-bc761eb36cb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VorOtek X-Series Headlight
• Version Model Number: VLHH-DA
• Catalog Number: VLHH-DA
• 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	09348227001181 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

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

Devices Manufactured by VOROTEK PTY LTD

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• 09348227002188 - VorOtek Speculums: 2023-09-18 VorOtek Speculums - Small. Pack of 50 Small Speculums. Autoclavable plastic
• 09348227002195 - VorOtek Speculums: 2023-09-18 VorOtek Speculums - XLarge. Pack of 50 XLarge Speculums. Autoclavable plastic
• 09348227002201 - VorOtek Speculums: 2023-09-18 VorOtek Speculums - XSmall. Pack of 50 XSmall Speculums. Autoclavable plastic
• 09348227000016 - VorOtek O Scope: 2023-08-17 VorOtek O Scope - SpecFrame - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 2 dioptre Magnificati
• 09348227000023 - VorOtek O Scope: 2023-08-17 VorOtek O Scope - HeadBand - 2D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 2 dioptre Magnificatio
• 09348227000092 - VorOtek L Scope: 2023-08-17 VorOtek L Scope - HeadBand. 2.5X Magnification Loupes @ 47cm working distance with Fully Integrated Surgical Quality Dimmable LE