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510(k) Data Aggregation

    K Number
    K212226
    Device Name
    DR Safety Syringe, Sterile Hypodermic needle for Single use
    Date Cleared
    2021-09-29

    (75 days)

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

    Zhuhai DR Medical Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    The DR Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe provided sterile and consists of the following components for 3ml and 5ml safety syringe: Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, Locking Ring and O-Ring. 0.5ml and 1ml safety syringe: Barrel, Plunger, Stopper, needle hub, needle tube, protective cap, Locking Ring and O-Ring The DR Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly/needle hub. Once the luer assembly/needle hub is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container. The DR Safety Syringes are available for 0.5mL, 1mL, 3mL, 5mL. The 0.5ml and 1ml DR Safety Syringes with fixed needle and 3ml, 5ml DR Safety Syringes with exchangeable needle are used to inject fluids into or withdraw fluids from the body. The DR Safety Syringes are designed to aid in the prevention of needle stick injuries
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