Sunoptic Technologies

Basic Information

• Brand Name: Sunoptic Technologies
• Primary DI: M678HLM0
• Version / Model: Headlights Molded
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Labeler DUNS: 094586898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 4
• Public Version Date: 2023-10-11
• Public Version Status: Update
• Public Device Record Key: e71a6af6-185c-4f0e-8c18-d5b9801ca8eb

Device Description

headlights molded

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EBA	Light, Surgical Headlight	Dental	872.4630	1

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	M678HLM0	HIBCC

Customer Contacts

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