KinesiaU 700-0025

GUDID 00859584006096

GREAT LAKES NEUROTECHNOLOGIES INC.

Tremor transducer

• Primary Device ID: 00859584006096
• NIH Device Record Key: 3e603854-3b8a-4eec-8501-165c1dbcfe03
• Commercial Distribution Discontinuation: 2019-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KinesiaU
• Version Model Number: 700-0025
• Catalog Number: 700-0025
• Company DUNS: 965540359
• Company Name: GREAT LAKES NEUROTECHNOLOGIES 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859584006096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063872

FDA Product Code

• GYD: Transducer, Tremor

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: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [KinesiaU]

• 00859584006096: 700-0025
• 00859584006157: 700-0027 KinesiaU Kit