BEUDAMED
    Product Code: GAJ FDA class 1 21 CFR 878.4800

    Stripper, Vein, Disposable

    General, Plastic Surgery

    The Stripper, Vein, Disposable (product code GAJ) is a single-use surgical instrument designed to remove veins, particularly varicose veins, from the extremities during general or plastic surgery procedures. It is classified as FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GAJ
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.