DEVICE: Pathway Pain & Sensory Evaluation System (07290103039301)

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Device Identifier (DI) Information

Pathway Pain & Sensory Evaluation System
Pathway
MO 00007-12
MEDOC LTD.
07290103039301
GS1
1
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.
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Device Characteristics

MR Conditional
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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.
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FDA Product Code

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Product Code Product Code Name
NTU Evoked Potential Stimulator, Thermal
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07290103039806 1 07290103039301 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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