Thermode 16X16 (TSA 2)

Basic Information

• Brand Name: Thermode 16X16 (TSA 2)
• Primary DI: 07290103039929
• Version / Model: Thermode 16X16
• Catalog Number: AS 00177
• Company Name: MEDOC LTD.
• Labeler DUNS: 600469191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 75db44a0-2610-494a-8dd8-c30c9f5c56ee

Device Description

Small Thermode 16X16

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
LQW	Test, Temperature Discrimination	Neurology	882.1200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37350	Thermotester, diagnostic	A mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290103039929	GS1