105 Deg Fiber Optic HL

GUDID 01816835024123

105 Deg Fiber Optic HL, Wolf Cable, Soft Headband

Medical Illumination International Inc.

Head-worn fibreoptic light

• Primary Device ID: 01816835024123
• NIH Device Record Key: ff80b45d-8385-4417-9b1e-ff93157d73bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 105 Deg Fiber Optic HL
• Version Model Number: 04-105VWS
• 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	00816835024124 [Primary]
GS1	01816835024123 [Package]; Contains: 00816835024124; 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 [105 Deg Fiber Optic HL]

• 01816835024147: 105 Deg Fiber Optic HL, Universal Cable, Soft Headband
• 01816835024130: 105 Deg Fiber Optic HL, Universal Cable, Ratchet Headgear
• 01816835024123: 105 Deg Fiber Optic HL, Wolf Cable, Soft Headband
• 01816835024116: 105 Deg Fiber Optic HL, Wolf Cable, Ratchet Headgear