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510(k) Data Aggregation

    K Number
    K152533
    Device Name
    Xonrid Gel
    Date Cleared
    2016-10-28

    (421 days)

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

    Helsinn Healthcare SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
    Device Description
    Xonrid® Gel is a multi-component prescription medical device product. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss. Xonrid® Gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a wellrecognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel. Xonrid® Gel provides a physical, topical barrier to the skin. The product is packaged in a 75 mL bottle equipped with an airless dispensing system and a cap. The bottle is manually operated, with each pump administering approximately 240 ul of product.
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