Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181933
    Device Name
    DePuy Synthes Sterilization Container System
    Manufacturer
    Synthes (USA) Products LLC / DePuy Orthopaedics Inc.
    Date Cleared
    2019-05-09

    (294 days)

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

    Synthes (USA) Products LLC / DePuy Orthopaedics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days. The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
    Device Description
    The DePuy Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards. The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.
    Ask a Question

    Page 1 of 1