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510(k) Data Aggregation

    K Number
    K090092
    Device Name
    SOCKIT! AND MCMERLIN DERMAL WOUND GEL
    Manufacturer
    MCMERLIN DENTAL PRODUCTS LP
    Date Cleared
    2009-05-11

    (117 days)

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

    MCMERLIN DENTAL PRODUCTS LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product provides for the management of and relieves the pain associated with all types of dermal wounds, skin sores, injuries and ulcers of the skin. Examples include: - · All types of dermal wounds, skin sores, injuries and ulcers of the skin - · First & Second degree burns - · Pressure ulcers, stages I IV - · Stasis ulcers - · Diabetic ulcers - · Radiation dermatitis - Post-surgical incision - · Surgical sites, including soft tissue graft sites - · Foot ulcers - Venous stasis ulcers - Cuts & Abrasions - · Partial thickness wounds - · Irritation of the skin - · Itching - · Sunbum - · Skin condition associated periostomy care - · Chemical peel - · Tattooing procedures - · Irritation and pain following skin Laser resurfacing treatment - · Irritation and pain following dermabrasion therapy This product provides for the management of and relieves the pain associated with all minor dermal wounds, minor skin sores, minor injuries and minor irritations of the skin. Examples include: - Minor burns - Minor Cuts & Abrasions - · Superficial itching - · Sunburn - · Minor burns from a chemical peel treatment - · Minor irritation and pain following tattooing procedures - · Minor irritation and pain following skin laser resurfacing treatment - · Minor irritation and pain following dermabrasion therapy
    Device Description
    Socklt!® Dermal Wound Gel/McMerlin® Dermal Wound Gel is a clear, viscous hydrogel wound dressing composed entirely of all-natural, food-grade, safe ingredients, including an all-natural preservative system. It is safe if swallowed, is designed to be physiologically compatible with both intact and compromised tissues of the skin, and will manage the pain associated with all types of injuries to the skin. The gel's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contours of the wound, and protects the wound from contamination and irritation by forming a profective barrier that is similar to dermal tissues. It also creates and maintains a moist wound environment, which is necessary for optimal healing. Socklt.10 Dermal Wound Gel/McMerlin® Dermal Wound Gel has been designed to be physiologically compatible with both intact and compromised tissues of the skin: the pH and osmotic pressure of the gel have been adjusted to be compatible with injured tissues. Socklt!® Dermal Wound Gel and McMerlin® Dermal Wound Get are exactly the same in every aspect, the same device has two different trade names.
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