BEUDAMED
    Product Code: ERY FDA class 2 21 CFR 878.4370

    Drape, Surgical, Ent

    General, Plastic Surgery

    The ENT surgical drape is a sterile barrier device used to create and maintain a clean field around the operative site during ear, nose, and throat surgical procedures. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ERY, regulated under 21 CFR 878.4370 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    ERY
    Device Class
    FDA class 2
    Regulation Number
    878.4370
    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 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.