BEUDAMED
    Product Code: MXP FDA class 1 21 CFR 874.4800

    Bone Particle Collector

    Ear, Nose, Throat

    The Bone Particle Collector is a surgical accessory used during ENT (ear, nose, and throat) procedures to collect bone particles and shavings generated during drilling or cutting, which can then be used as autologous graft material. Classified as FDA Class 1, it is subject to general controls under regulation 874.4800 (Ear, Nose, Throat specialty). Class 1 devices represent the lowest risk category and are generally the least regulated, though this device is not GMP-exempt.

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    510(k)s
    0
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MXP
    Device Class
    FDA class 1
    Regulation Number
    874.4800
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.