90 Deg Fiber Optic HL

GUDID 01816835024093

90 Deg Fiber Optic HL, Universal Cable, Ratchet Headgear

Medical Illumination International Inc.

Head-worn fibreoptic light

• Primary Device ID: 01816835024093
• NIH Device Record Key: a6bd30f0-4f73-433d-b4b4-b4150cab3923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 90 Deg Fiber Optic HL
• Version Model Number: 04-090VUR
• Company DUNS: 093357739
• Company Name: Medical Illumination International Inc.
• 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	00816835024094 [Primary]
GS1	01816835024093 [Package]; Contains: 00816835024094; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991572

FDA Product Code

• FST: Light, Surgical, Fiberoptic

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: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [90 Deg Fiber Optic HL]

• 01816835024109: 90 Deg Fiber Optic HL, Universal Cable, Soft Headband
• 01816835024093: 90 Deg Fiber Optic HL, Universal Cable, Ratchet Headgear
• 01816835024086: 90 Deg Fiber Optic HL, Wolf Cable, Soft Headband
• 00816835024070: 90 Deg Fiber Optic HL, Wolf Cable, Ratchet Headgear