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510(k) Data Aggregation

    K Number
    K242758
    Device Name
    Atrauman® Ag
    Manufacturer
    Hartmann USA, Inc.
    Date Cleared
    2024-12-09

    (88 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hartmann USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.
    Device Description
    Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
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