BEUDAMED
    Product Code: MOQ FDA class 1 21 CFR 878.4820

    Battery, Replacement, Rechargeable

    General, Plastic Surgery

    The Rechargeable Replacement Battery is a general surgery accessory designed to provide power to battery-operated medical devices, serving as a replacement power source that can be recharged for reuse. Classified as FDA Class 1 under 21 CFR 878.4820 in the General and Plastic Surgery specialty, it is 510(k)-exempt and subject only to general controls. The product code is MOQ.

    View on FDA
    510(k)s
    3
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    3
    Years Active
    11

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    Basic Information

    Product Code
    MOQ
    Device Class
    FDA class 1
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE
    K013133 NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
    K980224 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.