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510(k) Data Aggregation

    K Number
    K071517
    Device Name
    AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
    Manufacturer
    A.B.M. ITALIA S.P.A
    Date Cleared
    2008-04-02

    (303 days)

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

    A.B.M. ITALIA S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AP Medical sharps containers are intended for use by healthcare providers such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities for safe disposal of sharps such as Needles, Scalpels, Lancets and other Sharp Instruments. Three different lines are offered to our customers and end users: PBS line - disposable round containers with access inlets on the lid, for sharps disposal CS line - disposable square containers with rotating lid for sharps disposal NURSY line - disposable square containers with hermetic permanent closure for sharps disposal
    Device Description
    Our sharps containers are made of Polypropylene resin and coloured using Masterbatch which contains no heavy metals or cadmium. These materials allow us to produce a very safe, high quality puncture resistant container. Each container is comprised of a Body (either square or round) and a lid. The lids are a very safe and secure fit. All containers are vertical entry. All containers have the maximum filling level line as well as required labelling in accordance with current legislation. These containers are equipped with a permanent closure system, that is the final method of closure. Once the container is closed permanently it is locked closed. It can not manually re-open. This is a very safe method of preventing injury. Once the container is full it is locked and then disposed of. It is safe for anyone coming into contact with the container.
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