NovaSure


Product Overview

NovaSure - 2000


Device Description

A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: MNB

    Device Name: Device, Thermal Ablation, Endometrial

    Device Class: 3

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 2

    Review Panel: OB

    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: 15420045501140

    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


    Device Id: 25420045501147

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15420045501140

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BOX


    Device Id: 35420045501144

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 25420045501147

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CARTON


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