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    K Number
    K011840
    Device Name
    CERVILENZ UTERINE MEASURING SOUND
    Manufacturer
    CERVILENZ INC
    Date Cleared
    2001-08-10

    (59 days)

    Product Code
    HHM
    Regulation Number
    884.4530
    Why did this record match?
    Product Code :

    HHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
    Device Description
    The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.
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