CAUTERY HIGH TEMPERATURE ELONGATED TIP


Product Overview

CAUTERY HIGH TEMPERATURE ELONGATED TIP
Bovie - AA21X


Device Description

A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: HQP

    Device Name: Unit, Cautery, Thermal, Battery-Powered

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OP

    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: 886.4115

    Third Party Flag: Y

    Medical Specialty: OP


    Device Identifiers

    Device Id: 10607151008984

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00607151008987

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BOX


    Device Id: 00607151008987

    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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