Surgical Headlight

Basic Information

• Brand Name: Surgical Headlight
• Primary DI: 00857580006737
• Version / Model: Light Weight Single Adjustable Headgear
• Company Name: GULF FIBEROPTICS, INC.
• Labeler DUNS: 017416582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 1
• Public Version Date: 2019-11-19
• Public Version Status: New
• Public Device Record Key: 1a4dc3e3-e8af-4429-922e-de49cef6815c

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46808	Head-worn fibreoptic light	A fibreoptic device mounted on a headband or helmet frame to convey cold light from a connected light source (not included) directly onto the field of vision during a medical or surgical procedure. It typically consists of a magnifying lens, a reflector, and a fibreoptic cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857580006737	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061690	000