BEUDAMED
    Product Code: MRL FDA class 1 21 CFR 880.2740

    Scale, Sponge, Surgical, Electrically-Powered

    General Hospital

    The Electrically-Powered Surgical Sponge Scale is a general hospital device used in the operating room to weigh blood-soaked surgical sponges, enabling accurate estimation of intraoperative blood loss to guide transfusion decisions. Classified as FDA Class 1 under 21 CFR 880.2740 in the General Hospital specialty, it is 510(k)-exempt and subject only to general controls. The product code is MRL.

    View on FDA
    510(k)s
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MRL
    Device Class
    FDA class 1
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K964181 SPONGETRAC

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.