LEAD 6416-140S TEMP FIX LEAD SINGLE


Product Overview

LEAD 6416
NA - 6416-140S


Device Description

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 158.00
    • -40.00

  • Device Sizes

  • Catheter length 60 cm
  • Lead length 140 cm
    • Catheter length 60 cm
    • Lead length 140 cm


    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: 00885074212777

    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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