Fiberoptics Technology Inc

Basic Information

• Brand Name: Fiberoptics Technology Inc
• Primary DI: 00862658000326
• Version / Model: FTIHL
• Company Name: FIBEROPTICS TECHNOLOGY, INC.
• Labeler DUNS: 088324827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-26
• Public Version: 1
• Public Version Date: 2021-08-03
• Public Version Status: New
• Public Device Record Key: ee2f0fc5-32c2-495b-a452-7efcd1a2fa12

Device Description

Adjustable Surgical Headlight

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• 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
FCT	Headlight, Fiberoptic Focusing	Ophthalmic	886.4335	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32036	Headband, reusable	A device designed to be worn on the head of a healthcare provider for the mounting of another device, most commonly a head-worn light or a binocular indirect ophthalmoscope (BIO), so that the mounted device will remain directed in the user's line of vision despite head movement. It is typically adjustable for a custom fit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862658000326	GS1

Customer Contacts

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