AccessGUDID - DEVICE: Pathway Pain & Sensory Evaluation System (07290103039301)

GUDID

Device Identifier (DI) Information

Brand Name: Pathway Pain & Sensory Evaluation System
Version or Model: Pathway
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MO 00007-12
Company Name: MEDOC LTD.

Primary DI Number: 07290103039301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469191 *Terms of Use

Device Description: The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the functions offered by Medoc TSA-II, introducing new hardware and software capabilities to expand the quantitative investigation of human nociceptive pathways. The PATHWAY is a pain management and pain research system intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as cold and warm sensation and heat-induced pain. The Device includes: main unit, at least one probe/thermode 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
NTU	Evoked Potential Stimulator, Thermal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052357	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 388e1e56-7f28-4ec9-8f13-3e4e20295ad2
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016