BEUDAMED
    Product Code: LPG FDA class 3

    Material, Dressing, Surgical, Polylactic Acid

    Unknown

    The Polylactic Acid Surgical Dressing Material is a biocompatible, biodegradable material derived from polylactic acid, used as a wound dressing or barrier material in surgical settings to protect tissue and support healing. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) before it can be marketed, given the complexity of its interactions with tissue and the consequences of failure in a surgical context. The product code is LPG; no regulation number or specific medical specialty code is listed for this entry. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LPG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    DE
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.