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510(k) Data Aggregation

    K Number
    K242956
    Device Name
    LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
    Manufacturer
    OcuJect, LLC
    Date Cleared
    2024-10-25

    (30 days)

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

    QNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use. The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.
    Device Description
    The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.
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    K Number
    K231734
    Device Name
    STERiJECT Low Dead Space, STERiJECT The Invisible Needle
    Manufacturer
    TSK Laboratory International Japan KK
    Date Cleared
    2024-03-08

    (268 days)

    Product Code
    QNS, ONS
    Regulation Number
    880.5570
    Why did this record match?
    Product Code :

    QNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to inject into or aspirate from, the body.
    Device Description
    A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. 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 syringes. The devices are intended to be used by doctors, medical- related practitioners and self-injection by patients as directed by doctors or medical-related practitioners. The needle hub or connector of the needle is designed to reduce medication waste. Low dead space needles are operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intravascular, and intradermal.
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    K Number
    K210444
    Device Name
    EZ-Injec LDV Sterile Safety Needle
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2021-02-16

    (0 days)

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

    QNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.
    Device Description
    Sterile single use needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas. The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.
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