BEUDAMED
    Product Code: EYS FDA class 1 21 CFR 876.4560

    Ribdam

    Gastroenterology, Urology

    The ribdam is a device used to maintain and retract the ribs or abdominal wall during surgical procedures, providing mechanical exposure of the operative field in urological or general surgical operations. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission requirement. The product code is EYS, regulated under 21 CFR 876.4560 in the Gastroenterology, Urology specialty. No special regulatory flags apply.

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

    Product Code
    EYS
    Device Class
    FDA class 1
    Regulation Number
    876.4560
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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