Isolux llc

Basic Information

• Brand Name: Isolux llc
• Primary DI: 00852350007013
• Version / Model: FO-2088
• Catalog Number: 05-09WS
• Company Name: ISOLUX LLC
• Labeler DUNS: 828730973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c2187ba8-eb97-46f0-a38e-8ec812b57aee
• Distribution End Date: 2025-12-31

Device Description

Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852350007013	GS1

Customer Contacts

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