AccessGUDID - DEVICE: Contact Heat Evoked Potential Stimulator (07290103039318)

GUDID

Device Identifier (DI) Information

Brand Name: Contact Heat Evoked Potential Stimulator
Version or Model: CHEPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDOC LTD.

Primary DI Number: 07290103039318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469191 *Terms of Use

Device Description: The Modified Contact Heat Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as stimulator for creating sensation and pain stimuli in the sensory nerves fibers. the CHEPS indicated for the use in evaluating the functionality of human reception and transmission of sensory pathways The Device includes: main electrical unit, external cooling unit, at least one thermode probe and accessories.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQW	Test, Temperature Discrimination
NTU	Evoked Potential Stimulator, Thermal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85abe8b1-cd6e-4b46-97d4-82d1e23e56c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016