ILLUMINIX

GUDID 00860010833278

Refractor instrument for trial lenses for subjective eye refraction examiation

Illuminix Industries LLC

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• Primary Device ID: 00860010833278
• NIH Device Record Key: 2e6d44b9-e948-46b7-b85e-b88f656e5c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILLUMINIX
• Version Model Number: ESSENCE
• Company DUNS: 114867460
• Company Name: Illuminix Industries LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• 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: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com
• Phone: 1 800 290 5140
• Email: info@illuminixeye.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010833278 [Primary]

FDA Product Code

• HKN: Refractor, Manual, Non-Powered, Including Phoropter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [ILLUMINIX]

• 00860010833292: Auto Refractor and Keratometer
• 00860010833285: Chart Visual Acuity
• 00860010833278: Refractor instrument for trial lenses for subjective eye refraction examiation
• 00860010833261: Slitlamp instrument galileo ZS style microscope for eye examination
• 00860010833247: Slitlamp instrument galileo HS style microscope for eye examination
• 00860010833223: Stand for hold instruments for eye refraction examination
• 00860010833216: Chair with motorized elevation and reclining for patient still seated for eye refraction examina
• 00860010833209: Slitlamp instrument galileo HS style microscope for eye examination