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510(k) Data Aggregation

    K Number
    K242073
    Device Name
    STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
    Manufacturer
    TSK Laboratory International Japan KK
    Date Cleared
    2024-10-23

    (99 days)

    Product Code
    QYM
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    QYM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to inject into or aspirate from, the body. The device is intended for intravitreal use.
    Device Description
    The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringe. The device can be used by health care professionals. The hub of the needle can be a standard size or a reduced size (low dead space) that is designed to reduce medication waste. The device is operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intradermal, and intravitreal.
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    K Number
    K230951
    Device Name
    Terumo Injection Filter Needle (NF-3013RBKE05M)
    Manufacturer
    Terumo Europe N.V.
    Date Cleared
    2023-10-18

    (197 days)

    Product Code
    QYM
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    QYM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Terumo Injection Filter Needle is intended to inject fluids. The Terumo Injection Filter Needle is indication - for treatment - injection of fluids into parts of the body below the surface of the skin and into the vitreous.
    Device Description
    The Terumo Injection Filter Needle is a sterile injection needle for single use consisting of a stainless steel cannula with nominal outside diameter of 0.3 mm and length of 12 mm that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polymethyl methacrylate designed to be connected with a male luer connector (nozzle) of a syringe. The integrated 5u filter in the hub is intended to prevent particles from being injected. The needle is non-toxic, nonpyrogenic and sterilized by ethylene oxide. Its operation is manual. The Terumo Injection Filter Needle protector and is individually packed in a soft blister made of paper and film and sterilized by ethylene oxide.
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