RFA Single Electrode Kit


Product Overview

RFA Single Electrode Kit
Cool-tip - ACT2020


Device Description

A hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 25.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 149.00
    • -29.00
  • Special Storage Condition, Specify
    • Keep dry
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 30.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 104.00
    • 50.00

  • Device Sizes

  • tip exposure,2,Centimeter;
  • Length: 20 Centimeter
    • tip exposure,2,Centimeter;
    • Length: 20 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GEI

    Device Name: Electrosurgical, Cutting & Coagulation & Accessories

    Device Class: 2

    Physical State: N/A

    Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    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: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 878.4400

    Third Party Flag: Y

    Medical Specialty: SU


    Code: NEY

    Device Name: System, Ablation, Microwave And Accessories

    Device Class: 2

    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: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 878.4400

    Third Party Flag: Y

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884524001217

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884524001210

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884524001210

    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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