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510(k) Data Aggregation

    K Number
    K020664
    Device Name
    STERISHARP 3-GALLON RSDC, MODEL RSDC3G
    Manufacturer
    STERILOGIC WASTE SYSTEMS, INC.
    Date Cleared
    2002-05-14

    (74 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERILOGIC WASTE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SteriSharp™ 3-Gallon RSDC reusable containers are intended for use by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.
    Device Description
    The SteriSharp™ 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid and they are deposited automatically into the container. When the container is full the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, SteriLogic employees will empty and sanitize the unit and return it to your facility to use for the next switch out. The durable high-density polyethylene construction of the SteriSharp™ 3 makes it leak-proof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.
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    K Number
    K991612
    Device Name
    STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
    Manufacturer
    STERILOGIC WASTE SYSTEMS, INC.
    Date Cleared
    1999-05-28

    (18 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    STERILOGIC WASTE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.
    Device Description
    REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned.
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