NEEDLE 8263211 5PK 27G W/ELECTRODE ROHS


Product Overview

NEEDLE 8263211 5PK 27G W/ELECTRODE ROHS
ACCUGUIDE® - 8263211


Device Description

An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • 0.00

  • Device Sizes

  • Length: 37.0 Millimeter
  • Needle Gauge: 27.0 Gauge
    • Length: 37.0 Millimeter
    • Needle Gauge: 27.0 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: IKT

    Device Name: Electrode, Needle, Diagnostic Electromyograph

    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: 890.1385

    Third Party Flag: Y

    Medical Specialty: PM


    Code: GXZ

    Device Name: Electrode, Needle

    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: 882.1350

    Third Party Flag: Y

    Medical Specialty: NE


    Code: IKN

    Device Name: Electromyograph, Diagnostic

    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: 890.1375

    Third Party Flag: Y

    Medical Specialty: PM


    Device Identifiers

    Device Id: 20643169345007

    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


    Device Id: 00643169345003

    Device Type: Unit of Use

    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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