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510(k) Data Aggregation

    K Number
    K200242
    Device Name
    StaClear Syringe
    Manufacturer
    TriboFilm Research, Inc.
    Date Cleared
    2020-07-27

    (178 days)

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

    TriboFilm Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
    Device Description
    The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
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    K Number
    K071027
    Device Name
    TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
    Manufacturer
    TRIBOFILM RESEARCH, INC.
    Date Cleared
    2007-07-20

    (100 days)

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

    TRIBOFILM RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TriboGlide™ Lubricated Silicone-Free Syringe when combined with an appropriate gauge needle is used to inject fluids into, or withdraw fluids from, the body.
    Device Description
    The TriboGlide™ Silicone-Free Syringes are sterile and disposable (single use) standard polypropylene piston syringes without permanently attached needles. They consist of a polypropylene syringe barrel and plunger. Various syringe sizes include 0.5ml, 1ml, 3ml, 6ml, 10ml, 12ml, 60ml and 140ml. The lubricant used in the TriboGlide syringe is a fluorocarbon based non-silicone lubricant. The TriboGlide™ Silicone-Free Syringes, when combined with an appropriate gauge needle, are used to inject fluids into, and withdraw fluids from, the body.
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