KinesiaU 700-0027

GUDID 00859584006157

Great Lakes Neurotechnologies Inc.

Tremor transducer

• Primary Device ID: 00859584006157
• NIH Device Record Key: 352df1fd-792d-4f0c-a8cc-1286c6da64f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KinesiaU
• Version Model Number: 700-0027 KinesiaU Kit
• Catalog Number: 700-0027
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00859584006157 [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: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [KinesiaU]

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