Isolux llc 05-09WS

GUDID 00852350007013

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

ISOLUX LLC

Fibreoptic light cable

• Primary Device ID: 00852350007013
• NIH Device Record Key: c2187ba8-eb97-46f0-a38e-8ec812b57aee
• Commercial Distribution Discontinuation: 2025-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolux llc
• Version Model Number: FO-2088
• Catalog Number: 05-09WS
• Company DUNS: 828730973
• Company Name: ISOLUX LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 239-514-7475
• Email: nick@isoluxllc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852350007013 [Primary]

FDA Product Code

• FST: Light, Surgical, Fiberoptic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00852350007013]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-30

Devices Manufactured by ISOLUX LLC

• 00852350007006 - 1300XSB: 2019-02-21 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.
• 00852350007020 - OptiLux LED Illuminator: 2019-02-21 LED Illuminator Used For Surgical Instrument Illumination
• 00852350007013 - Isolux llc: 2018-03-29Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI
• 00852350007013 - Isolux llc: 2018-03-29 Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI