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510(k) Data Aggregation

    K Number
    K102222
    Device Name
    ULTIMATE VIT ENHAMCER (UVE)
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
    Date Cleared
    2011-04-08

    (245 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UVE and the MID Labs Vitreous Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Vitreous Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
    Device Description
    Ultimate Vit Enhancer is a standalone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine (Host system) for vitreous cutting. The UVE is used with the MID Labs Vitreous Cutter labeled for use with the UVE.
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    K Number
    K020911
    Device Name
    MID LABS AUTONOMOUS VIT ENHANCER (AVE)
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
    Date Cleared
    2002-04-29

    (40 days)

    Product Code
    HQE, HOE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVE is used in conjuction with ophthalmic surgical equipment (typically Pho AVE is assurent or vitreoretinal surgical equipment) to remove vitreous and intraocular tissue.
    Device Description
    Autonomous Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting.
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    K Number
    K992943
    Device Name
    VIT ENHANCER
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
    Date Cleared
    1999-12-10

    (101 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vit Enhancer in conjunction with standard vitrectomy equipment is used to remove vitreous and other intraocular tissue.
    Device Description
    Vit Enhancer is a stand alone console box with accessories, designed to be used in conjunction with a standard vitrectomy machine for vitreous cutting. The High Speed Vitreous Cutter is used with the Vit Enhancer.
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    K Number
    K971067
    Device Name
    DIGI-INJECTOR
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
    Date Cleared
    1997-09-19

    (179 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.
    Device Description
    Not Found
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