Tracker

GUDID B435OKN1

WESTERN SYSTEMS RESEARCH INC.

Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum Nystagmus inducing optokinetic drum

• Primary Device ID: B435OKN1
• NIH Device Record Key: 65fc0ef5-ac09-41dc-81a8-30d5abd0d537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracker
• Version Model Number: CUBE-OKN
• Company DUNS: 608365466
• Company Name: WESTERN SYSTEMS RESEARCH INC.
• 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: false
• Serial Number: true
• 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
HIBCC	B435OKN1 [Primary]

FDA Product Code

• HOW: Drum, Opticokinetic

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: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by WESTERN SYSTEMS RESEARCH INC.

• B435ENGEV2000 - ENGplus™: 2023-08-17
• B435MT07 - MotionTrak: 2023-07-05
• B435OKN1 - Tracker: 2023-07-05
• B435OKN1 - Tracker: 2023-07-05
• B435EV2000 - VAT®: 2018-07-06