BEUDAMED
    Product Code: HDM FDA class 1 21 CFR 884.4520

    Packer, Uterine

    Obstetrics/Gynecology

    The Uterine Packer is a gynecological instrument used to introduce packing material, such as gauze, into the uterine cavity to control postpartum hemorrhage or to provide compression following uterine procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDM under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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    510(k)s
    0
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HDM
    Device Class
    FDA class 1
    Regulation Number
    884.4520
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    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 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.