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510(k) Data Aggregation

    K Number
    K061933
    Device Name
    HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER
    Manufacturer
    HAGER WORLDWIDE, INC.
    Date Cleared
    2006-11-16

    (132 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAGER WORLDWIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIRAMATIC Box Sharps Container is intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. For use with 25, 27 and 30 gauge long and short dental needles. The Cap Trap Needle Re-capper is intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal.
    Device Description
    The MIRAMATIC Box Sharps Container is designed for use with the MIRAMATIC cartridge syringe to enable single-handed disengagement, ejection and disposal of needles during dental procedures. The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow single-handed re-sheathing so that the needle is re-sheathed without directing it toward any part of the body. It consists of a base, carrier plate and activation plate.
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    K Number
    K043322
    Device Name
    MIRAMATIC SAFE SYRINGE SYSTEM
    Manufacturer
    HAGER WORLDWIDE, INC.
    Date Cleared
    2005-07-21

    (231 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAGER WORLDWIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The cartridge syringe may aid in the reduction of needle stick injuries.
    Device Description
    The Hagar MIRAMATIC System consists of a cartridge syringe (the MIRAMATIC) and dental needles (MIRAJECT). The MIRAMATIC System is a manual system designed exclusively for use with MIRAJECT needles. The hub of the syringe is designed to receive the needle using a compression fit mechanism rather than a threaded screw-on motion or slip-fit. The needles have a corresponding specially designed cone to allow seating by push fit on to the hub. The syringe hub has locked and unlocked positions.
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    K Number
    K050658
    Device Name
    RESO-PAC PERIODONTAL DRESSING
    Manufacturer
    HAGER WORLDWIDE, INC.
    Date Cleared
    2005-05-27

    (74 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAGER WORLDWIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.
    Device Description
    The product is a periodontal wound dressing. It is intended for use only by dental practitioners; and will not be offered for OTC use. It contains materials that pose no health hazard when used according to directions.
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