EYE-SYNC

GUDID 00868096000300

SYNC-THINK, INC.

Vision/eye movement analysis system

• Primary Device ID: 00868096000300
• NIH Device Record Key: 237284f1-f43b-4ab2-be8f-ed74843d577c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EYE-SYNC
• Version Model Number: X02
• Company DUNS: 966659307
• Company Name: SYNC-THINK, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-221-3813
• Email: support@syncthink.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868096000300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152915

FDA Product Code

• GWN: Nystagmograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-21