AccessGUDID - DEVICE: Q-Sense Thermal Sensory Analazer (07290103039202)

GUDID

Device Identifier (DI) Information

Brand Name: Q-Sense Thermal Sensory Analazer
Version or Model: Q-Sense
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MO 00013
Company Name: MEDOC LTD.

Primary DI Number: 07290103039202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469191 *Terms of Use

Device Description: The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The Q-Sense is a pain management and pain research intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as the sensation of warmth, cold, heat-induced pain and cold-induced pain. The Device includes: main unit, one thermode/probe and accessories.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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

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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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922052	000

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: ce287f6c-0d55-4bd1-b7cf-a6c4fe929521
Public Version Date: August 16, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016