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510(k) Data Aggregation

    K Number
    K081455
    Device Name
    RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
    Manufacturer
    RAYNER SURGICAL INC
    Date Cleared
    2008-09-05

    (105 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAYNER SURGICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use small incision disposable injector (model number R-INJ-06) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
    Device Description
    The single-use small incision disposable injector (model number R-INJ-06) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The small incision injector (model number R-INJ-06) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white.
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    K Number
    K062612
    Device Name
    RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
    Manufacturer
    RAYNER SURGICAL INC
    Date Cleared
    2006-12-13

    (99 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAYNER SURGICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
    Device Description
    The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene. The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip.
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    K Number
    K052651
    Device Name
    C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
    Manufacturer
    RAYNER SURGICAL INC
    Date Cleared
    2006-01-19

    (115 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAYNER SURGICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable single-use injector (model number R-INJ-02) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
    Device Description
    The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. The injector is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The disposable single-use injector is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.
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