Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K110867
    Device Name
    STERI-DENT, STERI-SURE
    Manufacturer
    CPAC, INC.
    Date Cleared
    2011-07-20

    (113 days)

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

    CPAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steri-Dent / Steri-Sure Self-Seal Nylon Pouch is intended to be used to allow sterilization of enclosed medical instruments by a dry heat sterilizer operating at 160°C (320°F) for 1 hour (60 minutes) and also to maintain the sterility of the enclosed instruments for 30 days after sterilization.
    Device Description
    The Steri-Dent Self-Seal Nylon Pouches are single use sterilization wraps that provide a means for health care providers to enclose metal instruments, which are sterilized in a dry heat sterilizer, and to maintain sterility of the instruments until they are used. The pouches can be used in dry heat sterilizers with a sterilization cycle of 1 hour (60 minutes) operating at 160°C (320°F) such as the Steri-Dent Model 2100 and 3100. The nylon pouches will maintain the sterility of the instruments for a maximum of 30 days. If the instruments inside the pouch are not used within 30 days after being sterilized, they should be removed, placed in a new bag and resterilized.
    Ask a Question
    K Number
    K094026
    Device Name
    STERI-DENT, STERI-SURE
    Manufacturer
    CPAC, INC.
    Date Cleared
    2011-07-12

    (559 days)

    Product Code
    KMH
    Regulation Number
    880.6870
    Why did this record match?
    Applicant Name (Manufacturer) :

    CPAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes).
    Device Description
    The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). Items to be sterilized are placed horizontally on the removable trays inside the chamber. Both models are plug-in units designed to run on standard 115 VAC household current. A thermocouple is used to measure the chamber temperature. All functions of the sterilizer are controlled by an embedded PCB. Access to the heating chamber is through a hinged door on the front of unit. A LED digital display located on the front of the unit indicates chamber temperature and remaining cycle time.
    Ask a Question

    Page 1 of 1