Altair SA

Basic Information

• Brand Name: Altair SA
• Primary DI: 00860013851538
• Version / Model: QED-1201
• Company Name: QED, INC.
• Labeler DUNS: 877534289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-21
• Public Version: 1
• Public Version Date: 2025-05-29
• Public Version Status: New
• Public Device Record Key: 3b86092f-b3b9-4d8d-b51a-4790c4e7196a

Device Description

Fiber Optic 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
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	00860013851538	GS1

Customer Contacts

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