DEVICE: Algomed Computerized Pressure Algometer (07290103039059)

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Device Identifier (DI) Information

Algomed Computerized Pressure Algometer
FPIX
AS 00300
MEDOC LTD.
07290103039059
GS1
1
The Algometer provides pain diagnostic testing with digital clarity and computer interface for data logging. The AlgoMed Computerized Pressure Algometry is an Algometry device including advanced software package designed for clinical use and advance research in the field of Pain Management. The AlgoMed enables the user to perform various pressure test paradigms including the method of limits and the ramp and hold method. These test paradigms can be utilized for a wide range of pressure pain measures such as pressure pain threshold and tolerance, temporal summation, DNIC and more. The device can also evaluate disease or treatment progress over time.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Pressure algesimeter A manual instrument designed to measure a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force to the skin. It typically consists of a sharp needle, a blunt tip, and a strain gauge; the pressure needed to feel the pain produced by the sharp point of the needle, as measured by the pressure exerted on an adjacent blunt tip in unaffected areas, is used to determine the pain threshold (15 grams is considered typical). The device is typically used to evaluate the effects of pain after the use of analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HRW Dynamometer, Nonpowered
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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
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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
07290103039554 1 07290103039059 In Commercial Distribution Carton Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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Unit of Use DI

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Direct Marking (DM)

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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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