Product Overview

SMARTABLATE - D130303


Device Description

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Do not use if package is damaged
  • Special Storage Condition, Specify
    • Do not use if package is opened
  • Special Storage Condition, Specify
    • Keep out of direct sunlight
  • Special Storage Condition, Specify
    • Keep Dry
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 5.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: LPB

    Device Name: Cardiac Ablation Percutaneous Catheter

    Device Class: 3

    Physical State: N/A

    Definition: This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

    Submission Type ID: 2

    Review Panel: CV

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 10846835012644

    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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