STEELEX ELEC 2/0 (3) 60CM HR26/GS65V


Product Overview

STEELEX ELEC 2/0 (3) 60CM HR26/GS65V
Steelex - G0992097


Device Description

A sterile, flexible tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • -20.00

  • Device Sizes

  • Thread Material : stainless steel
  • Length: 60 Centimeter
  • Size of Thread (USP - Others) : 2/0
    • Thread Material : stainless steel
    • Length: 60 Centimeter
    • Size of Thread (USP - Others) : 2/0


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LDF

    Device Name: Electrode, Pacemaker, Temporary

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.3680

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 04038653926183

    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: 04046963064860

    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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