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510(k) Data Aggregation

    K Number
    K060971
    Device Name
    OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
    Date Cleared
    2006-10-24

    (200 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMI MANUFACTURING PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries. This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.
    Device Description
    The OMI Retractable Safety Syringe is a Sterile, Non Toxic, Non Pyrogenic, Latex Free, Single Use, automatically activated anti-stick piston syringe with integral needle. Available in 1ml, 3ml and 10ml sizes with various needle sizes. The OMI Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the plunger immediately after patient injection. Needle retraction is activated by the syringe user. The primary intended use is to administer safe and accurate subcutaneous and intramuscular injections. The secondary intended use is to retract and contain the contaminated needle after injection for the purpose of aiding in the prevention of accidental needle stick injuries.
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    K Number
    K032242
    Device Name
    PERSONNA PLUS SAFETY SCALPEL SYSTEM
    Date Cleared
    2003-09-23

    (64 days)

    Product Code
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMI MANUFACTURING PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
    Device Description
    The device is a combination scalpel blade and handle incorporating a sharps injury protection feature. There are two product options -(1) a totally disposable unit and (2) a metal handle with disposable blade and guard - our "reposable" product. The totally disposable unit uses a plastic handle while the reposable product has a stainless steel handle.
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