105 Deg Fiber Optic HL

Basic Information

• Brand Name: 105 Deg Fiber Optic HL
• Primary DI: 00816835024124
• Version / Model: 04-105VWS
• Company Name: Medical Illumination International Inc.
• Labeler DUNS: 093357739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-02
• Public Version: 1
• Public Version Date: 2023-10-10
• Public Version Status: New
• Public Device Record Key: ff80b45d-8385-4417-9b1e-ff93157d73bc

Device Description

105 Deg Fiber Optic HL, Wolf Cable, Soft Headband

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
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
Package	01816835024123	GS1	BOX	1	In Commercial Distribution
Primary	00816835024124	GS1

Premarket Submissions

Submission Number	Supplement Number
K991572	000