BEUDAMED
    Product Code: FXZ FDA class 1 21 CFR 878.4040

    Helmet, Surgical

    General, Plastic Surgery

    A surgical helmet is a protective head covering worn in the operating room, typically used in procedures requiring enhanced barrier protection for the surgical team against blood, fluid, or aerosol exposure. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXZ, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    FXZ
    Device Class
    FDA class 1
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    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 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.