BEUDAMED
    Product Code: QOJ FDA not classified

    Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)

    Unknown

    The Wall Vacuum-Powered Suction Apparatus for Operating Room Use (Export Only) is a suction device intended to be used for the removal of prosthetic breast implant specimens during surgical procedures. It is classified for export only and is not formally classified for the US market (unclassified, export only), with no regulation number assigned. Product code QOJ, reviewed by the General and Plastic Surgery panel. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QOJ
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to be used for the removal of prosthetic breast implant specimens.

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.