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510(k) Data Aggregation

    K Number
    K171191
    Device Name
    Hexagen Derm
    Manufacturer
    Global Health Solutions, LLC
    Date Cleared
    2017-08-25

    (123 days)

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

    Global Health Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, and radiation dermatiis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum (95%), water, and the antimicrobial preservatives Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Hexagen Derm's petrolatum base locks in moisture at the skin surface to keep wounded skin moist. Hexagen Derm is non-sterile, RX only, and available in 30 and 90 gram low density polyethylene tubes.
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    K Number
    K160872
    Device Name
    PolyPlex Wound Dressing
    Manufacturer
    GLOBAL HEALTH SOLUTIONS, LLC
    Date Cleared
    2016-11-23

    (238 days)

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

    GLOBAL HEALTH SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, postsurgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.
    Device Description
    PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion intended to maintain a moist environment that is conducive to healing. The product contains the preservatives polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK) to prevent microbial colonization within the dressing.
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