BEUDAMED
    Product Code: PLY FDA class 2 21 CFR 878.4370

    Antimicrobial Drapes

    General, Plastic Surgery

    The Antimicrobial Drapes (product code PLY) are Class 2 general and plastic surgery devices used to reduce the risk of skin flora contamination of the surgical wound during surgical procedures, regulated under 878.4370. They require 510(k) clearance and fall within the general and plastic surgery medical specialty. The devices are not implants and are not life-sustaining.

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

    Basic Information

    Product Code
    PLY
    Device Class
    FDA class 2
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    Definition

    Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure.

    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.