BEUDAMED
    Product Code: NTC FDA class 1 21 CFR 880.5630

    Nursing Pad, Hydrogel

    General Hospital

    The Hydrogel Nursing Pad is a product used by breastfeeding women, typically designed to provide soothing moisture and comfort to the nipple and areola area. As an FDA Class 1 device regulated under 21 CFR 880.5630 in the General Hospital specialty with product code NTC, it is subject to general controls and is exempt from premarket notification. No definition text is provided in the classification record, but the device name indicates its use in nursing care. It does not carry implant or life-sustaining support designations.

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    510(k)s
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NTC
    Device Class
    FDA class 1
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K030901 MEDTRADE PRODICT'S SOOTHING GEL PATCH

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.