DEVICE: Thermal Sensory Analazer (07290103039103)
Device Identifier (DI) Information
Thermal Sensory Analazer
TSA-II
In Commercial Distribution
MO 00004
MEDOC LTD.
TSA-II
In Commercial Distribution
MO 00004
MEDOC LTD.
The Thermal Sensory Analyzer TSA-II is a computer controlled device capable of generating and documenting response to highly repeatable thermal stimuli which 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 and accessories.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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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
[?]Product Code | Product Code Name |
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LQW | Test, Temperature Discrimination |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K922052 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
1e1c38a0-0e8d-4d78-a79f-b82b74ce09ed
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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07290103039608 | 1 | 07290103039103 | In Commercial Distribution | Carton |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined