OTUS® Fixation, Vision Training, Binocular

GUDID 08809765430006

Vision Training Device, Battery-powered

EDENLUX Corp.

Vision training device, battery-powered

• Primary Device ID: 08809765430006
• NIH Device Record Key: 96ea5c65-aa4d-463b-9580-bc85245a7613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTUS® Fixation, Vision Training, Binocular
• Version Model Number: LRS2-400FB1-M0
• Company DUNS: 696950408
• Company Name: EDENLUX Corp.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809765430006 [Primary]

FDA Product Code

• NXR: Fixation, Vision Training, Binocular

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: 2025-07-15
• Device Publish Date: 2025-07-07