Non-REM Polyhesive Patient Return Electrode


Product Overview

Non
Valleylab - E7506


Device Description

A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 0.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 149.00
    • -29.00

  • Device Sizes

  • Length: 9 Feet
    • Length: 9 Feet


    Device Sterilization

    Device Sterile: False

    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


    Device Identifiers

    Device Id: 20884524000982

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884524000985

    Package Quantity: 50

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884524000985

    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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