Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141412
    Device Name
    STERILUCENT SELF-SEAL STERILIZATION POUCH
    Date Cleared
    2014-12-03

    (188 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    GS MEDICAL PACKAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterilucent Self-Seal Sterilization Pouch is intended to be used to enclose medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterlity of the enclosed device until used. The pouches are intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles.
    Device Description
    The Sterilucent Self-Seal Sterilization Pouch is a self sealing pouch used to enclose another medical device that is to be sterilized by a healthcare provider. It is available in sizes to suit the healthcare provider. Devices are inserted into the pouch, sealed, and then sterilized in the Sterilucent low temperature vaporized hydrogen peroxide (VHP) process. After completion of the sterilization process, the pouch maintains sterility of the enclosed medical devices until the seal is opened. The pouches are constructed of a Tyvek backing with a clear, laminated polyethylene terephthalate (PET)/low density polyethylene (LDPE) film material front. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1