BEUDAMED
    Product Code: HXT FDA class 1 21 CFR 878.4800

    Tape, Orthopedic

    General, Plastic Surgery

    Orthopedic tape is a reinforced or non-extensible tape used in surgical settings to mark, protect, bundle, or temporarily secure tissues, cables, or instruments during orthopedic or general surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating low risk and general controls only. Product code HXT falls under the General and Plastic Surgery medical specialty.

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    510(k)s
    0
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    HXT
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.