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    K Number
    K150208
    Device Name
    Dakin's Skin and Wound Cleanser
    Manufacturer
    CENTURY PHARMACEUTICALS, INC.
    Date Cleared
    2016-07-21

    (538 days)

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

    CENTURY PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites. Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.
    Device Description
    The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier. Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.
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    K Number
    K090791
    Device Name
    DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
    Manufacturer
    CENTURY PHARMACEUTICALS, INC.
    Date Cleared
    2009-08-07

    (136 days)

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

    CENTURY PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.
    Device Description
    The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume. Sodium hypochlorite is a solution preservative.
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