PROBE 60SF2 CRYOFLEX 10CM 26L


Product Overview

PROBE 60SF2 CRYOFLEX 10CM 26L
Cardioblate® CryoFlex® - 60SF2


Device Description

An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 66.00
    • -40.00

  • Device Sizes

  • Length: 10.0 Centimeter
    • Length: 10.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OCL

    Device Name: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    Device Class: 2

    Physical State: The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue

    Definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Cardiac tissue.

    Regulation Number: 878.4400

    Third Party Flag: Y

    Medical Specialty: SU


    Device Identifiers

    Device Id: 00763000114619

    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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