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510(k) Data Aggregation

    K Number
    K171520
    Device Name
    SteriZign Signatur Device Protection System
    Date Cleared
    2018-02-07

    (259 days)

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

    SteriZign Precision Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. SteriZign Signatur Device Protection System are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Protection System are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Protection System are not intended on their own to maintain sterility. The SteriZign Signatur Device Protection System have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap. Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs. Validated sizes of stainless steel instrument lumens include: 1 each 1mm x 76 mm 1 each 1mm x 400 mm 1 each 2mm x 400 mm 1 each 3mm x 400 mm 1 each 5mm x 400 mm
    Device Description
    SteriZign Signatur Device Protection System are cassettes/trays used to enclose and hold surgical instruments and accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with a cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize and protect the surgical instruments within the cassettes/trays.
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