Surgical Headlight

GUDID 00857580006379

A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source.

GULF FIBEROPTICS, INC.

Head-worn fibreoptic light

• Primary Device ID: 00857580006379
• NIH Device Record Key: 8bbd6ae7-ecfb-48c9-a154-bb9a2ca6fdb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Headlight
• Version Model Number: Premium Double Adjustable Headgear
• Company DUNS: 017416582
• Company Name: GULF FIBEROPTICS, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 813-855-6618
• Email: contact@gulffiberoptics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857580006379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061690

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Surgical Headlight]

• 00857580006386: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea
• 00857580006379: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea
• 00857580006737: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehea