BEUDAMED
    Product Code: NOC FDA class 1 21 CFR 878.3910

    Splint, Extremity, Non-Inflatable, External, Non-Sterile

    General, Plastic Surgery

    The non-sterile non-inflatable external extremity splint is a surgical support device used to immobilize and protect injured or post-operative extremities such as arms and legs without the use of air or fluid inflation. It is classified as FDA Class 1 under regulation 878.3910 in the General and Plastic Surgery specialty, and it is GMP exempt. Product code NOC does not require a 510(k) submission and is associated with product code FYH.

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    510(k)s
    0
    FEI Numbers
    168
    Registration Numbers
    168
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NOC
    Device Class
    FDA class 1
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    Definition

    Non-inflatable extremity splint; See product code fyh.

    FEI Numbers

    This FDA classification entry is associated with 168 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 168 registration numbers. Click on an entry to view related FDA registrations.