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510(k) Data Aggregation

    K Number
    K200767
    Device Name
    SilverStream Gel
    Manufacturer
    Date Cleared
    2020-10-08

    (197 days)

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

    EnzySurge Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prescription Use: SilverStream Gel is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, cuts abrasions and minor skin irritations. OTC Use: SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
    Device Description
    SilverStream Gel is a clear hypertonic, non-pyrogenic liquid gel, designed for the management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, cuts abrasions, minor skin irritations, minor cuts, minor burns, abrasions and irritated areas. The action of SilverStream Gel is achieved by moisturizing wounds and maintaining wound moisture between dressing changes. A maintaining of the moist environment in the wound has been shown to be conducive to wound healing. Silver, serves as a preservative which, based on in vitro testing, inhibits the growth of microorganisms within the product during the shelf storage. The SilverStream Gel is supplied in 60mL polyethylene terephthalate (PETG) bottles. A pump head for dispensing is also supplied.
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