BEUDAMED
    Product Code: LMF FDA class 3 21 CFR 878.4490

    Agent, Absorbable Hemostatic, Collagen Based

    General, Plastic Surgery

    Agent, Absorbable Hemostatic, Collagen Based is a collagen-derived hemostatic agent applied during surgical procedures to control bleeding from wound surfaces; it works by providing a scaffold that promotes platelet adhesion and aggregation, and is absorbed by the body over time. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA), and is regulated under 21 CFR 878.4490 within the General/Plastic Surgery specialty. The product code is LMF. This device is an implant.

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    510(k)s
    0
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LMF
    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 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.