Needle Electrode Pair YE/BK, 15x1000mm


Product Overview

Needle Electrode Pair YE/BK, 15x1000mm
NA - 5140-533-633


Device Description

A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • TRANSPORT: 10-90%, -20+50¿C
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 30.00
  • Storage Environment Temperature - Degrees Celsius
    • 35.00
    • 4.00

  • Device Sizes

  • Length: 15.0 Millimeter
    • Length: 15.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GWF

    Device Name: Stimulator, Electrical, Evoked Response

    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: 882.1870

    Third Party Flag: Y

    Medical Specialty: NE


    Device Identifiers

    Device Id: 37613327292115

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327292114

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 07613327292114

    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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