BEUDAMED
    Product Code: MMS FDA class 1 21 CFR 880.6375

    Lubricant, Vaginal, Patient

    General Hospital

    The Patient Vaginal Lubricant is a personal use topical product applied to the vaginal area to reduce friction and discomfort during gynecological examinations, intercourse, or in the management of vaginal dryness associated with hormonal changes or other conditions. Classified as a Class 1 device under 21 CFR 880.6375 within the General Hospital specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MMS
    Device Class
    FDA class 1
    Regulation Number
    880.6375
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.