Product Overview

Entropy - GE Entropy sensor, M1038681


Device Description

A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GXY

    Device Name: Electrode, Cutaneous

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 882.1320

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 20840682102951

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00840682102957

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 00840682102957

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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