Reusable Battery Pack


Product Overview

Reusable Battery Pack
Sonicision - SCBA


Device Description

An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -22.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 15.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 50.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LFL

    Device Name: Instrument, Ultrasonic Surgical

    Device Class: U

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: 1

    Implant Flag: N

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 10884521592889

    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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