Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123234
    Device Name
    ERMIS STERILIZATION CONTAINER SYSTEM
    Date Cleared
    2013-07-05

    (263 days)

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

    ERMIS MEDIZINTECHNIK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, ¾ Size, ½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. The containers are reusable devices designed to be used with the following sterilization cycle parameters: Pre Vacuum cycle: 4 minutes 132°C (270°F) Drying Time minimum 20 minutes 3 minutes 135°C (273°F) Drying Time minimum 16 minutes Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles
    Device Description
    Ermis Medizintechnik Sterilization Container Systems are reusable devices intended to allow sterilization of enclosed medical devices and to maintain sterility of the enclosed devices until used. - Interchangeable components within the different sizes (Full size, ¼ size, ½ size, Wide Body, Den-. tal, Mini, Flat). - Containers are available with perforated and non-perforated bottom and perforated lids. . - Safety lids are available for 1/1 size, 3/4 size and 1/2 size. Safety lids protect filters during storage . and/or transportation. The Lids are not intended to be used during sterilization. - The lids are equipped with a silicone based gasket. . - All containers incorporate a filter system to be used with Ermis disposable paper filters without . chemical indicator. - To ensure effective sterilization and organization of sterilized goods, wire and screen baskets are . available.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1