RightEye Vision System

GUDID 00860010031902

RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time.

Righteye, LLC

Vision physiology/eye movement analysis system

• Primary Device ID: 00860010031902
• NIH Device Record Key: 98396f52-8024-467a-a662-719eabacdae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RightEye Vision System
• Version Model Number: Tobii Dynavox i15
• Company DUNS: 078642557
• Company Name: Righteye, LLC
• 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: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010031902 [Primary]

FDA Product Code

• GWN: Nystagmograph

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: 2023-03-13
• Device Publish Date: 2023-03-03