BEUDAMED
    Product Code: EXM FDA class 1 21 CFR 876.5970

    Truss, Umbilical

    Gastroenterology, Urology

    The umbilical truss is an external support device worn around the abdomen to apply pressure over an umbilical hernia, reducing protrusion and providing symptomatic relief, particularly in infants and young children. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is EXM, regulated under 21 CFR 876.5970 in the Gastroenterology, Urology specialty. This device is GMP exempt, meaning it is not subject to the full quality system regulation manufacturing requirements.

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    510(k)s
    0
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EXM
    Device Class
    FDA class 1
    Regulation Number
    876.5970
    Medical Specialty
    Gastroenterology, Urology
    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 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.