BEUDAMED
    Product Code: NUR FDA class 1 21 CFR 884.5435

    Pad, Menstrual, Intralabial

    Obstetrics/Gynecology

    The Interlabial Pad is an absorbent device made of cellulosic or synthetic material that is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge, fitting between the labia rather than externally in underwear. It is an FDA Class 1 device regulated under 21 CFR 884.5435 in the Obstetrics/Gynecology specialty, with product code NUR, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NUR
    Device Class
    FDA class 1
    Regulation Number
    884.5435
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    Definition

    An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.