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510(k) Data Aggregation

    K Number
    K211943
    Device Name
    Microlyte Ag/Lidocaine
    Manufacturer
    Date Cleared
    2024-10-17

    (1212 days)

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

    Imbed Biosciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, first degree burns, partial thickness burns, abrasions and lacerations.
    Device Description
    Microlyte® Ag/Lidocaine Wound Dressing is a sterile, single use absorbent polymeric matrix composed primarily of synthetic polyvinyl alcohol with 2.5 mg/in² of lidocaine hydrochloride USP, with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.1 mg/in² of silver.
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    K Number
    K153756
    Device Name
    Microlyte Ag
    Date Cleared
    2016-08-04

    (218 days)

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

    IMBED BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-thecounter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds.
    Device Description
    Microlyte™ Ag wound dressing is a sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch.
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