BEUDAMED
    Product Code: EXG FDA class 1 21 CFR 876.5900

    Bag, Urine Collecting, Ureterostomy

    Gastroenterology, Urology

    The ureterostomy urine collecting bag is a collection device worn externally to collect urine from a ureterostomy stoma, where one or both ureters have been diverted directly through the abdominal wall. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EXG, regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

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    510(k)s
    0
    FEI Numbers
    56
    Registration Numbers
    56
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    EXG
    Device Class
    FDA class 1
    Regulation Number
    876.5900
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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 56 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.