BEUDAMED
    Product Code: LMG FDA class 3 21 CFR 878.4490

    Agent, Absorbable Hemostatic, Non-Collagen Based

    General, Plastic Surgery

    Agent, Absorbable Hemostatic, Non-Collagen Based is a non-collagen hemostatic agent used during surgery to control local bleeding; it provides a hemostatic matrix that supports clot formation and is subsequently absorbed by the body, available in forms such as oxidized regenerated cellulose, gelatin sponge, or similar materials. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA), regulated under 21 CFR 878.4490 within the General/Plastic Surgery specialty. The product code is LMG. This device is an implant.

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    510(k)s
    0
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LMG
    Device Class
    FDA class 3
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.