KinesiaU

Basic Information

• Brand Name: KinesiaU
• Primary DI: 00859584006096
• Version / Model: 700-0025
• Catalog Number: 700-0025
• Company Name: Great Lakes Neurotechnologies Inc.
• Labeler DUNS: 965540359
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 2
• Public Version Date: 2021-03-03
• Public Version Status: Update
• Public Device Record Key: 3e603854-3b8a-4eec-8501-165c1dbcfe03
• Distribution End Date: 2019-10-21

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GYD	Transducer, Tremor	Neurology	882.1950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32546	Tremor transducer	A device used together with a parent device (e.g., a tremograph) for the measurement of the degree of tremor caused by certain diseases. This can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859584006096	GS1

Premarket Submissions

Submission Number	Supplement Number
K063872	000