BEUDAMED
    Product Code: MZM FDA class 2 21 CFR 880.5860

    Fibrin Sealant Preparation Device

    General Hospital

    The Fibrin Sealant Preparation Device is a general hospital device used to prepare fibrin sealant from a patient's own blood or from donor plasma components, combining fibrinogen and thrombin to create a biological adhesive used for hemostasis and tissue sealing during surgery. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 880.5860 (General Hospital specialty). This device is reviewed by the Hematology panel.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MZM
    Device Class
    FDA class 2
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.