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    K Number
    K221356
    Device Name
    Wee Bell
    Manufacturer
    wee MEDICAL
    Date Cleared
    2023-02-02

    (268 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    wee MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.
    Device Description
    The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed. The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.
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