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510(k) Data Aggregation

    K Number
    K100998
    Device Name
    1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
    Date Cleared
    2010-08-30

    (140 days)

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

    UNILIFE MEDICAL SOLUTIONS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Unitract Tuberculin Syringe, as supplied, is a device with a small barrel, plunger, and fixed needle, calibrated in milliliters (0.01 increments) to be used to administer (infuse) medication subcutaneous, intramuscular, or intradermal. It incorporates features that include reuse prevention (auto-disable) and sharps injury prevention (automatic needle retraction).
    Device Description
    The 1mL Unitract® Tuberculin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied as 27G x 1/2". The devices function in a manner similar to standard syringes, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature. The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
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    K Number
    K093400
    Device Name
    1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
    Date Cleared
    2010-04-01

    (150 days)

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

    UNILIFE MEDICAL SOLUTIONS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
    Device Description
    The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½". The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature. The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention. The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
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    K Number
    K080877
    Device Name
    1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
    Date Cleared
    2008-10-21

    (204 days)

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

    UNILIFE MEDICAL SOLUTIONS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The syringe as supplied is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.
    Device Description
    The 1mL Unitract® Insulin Syringe is a sterile, fixed needle, single use, insulin (U-100) syringe, consisting of a barrel and plunger assembly. The syringe is supplied in two needle sizes, being 27G x ½" and 29G x ½". The devices function in a manner similar to standard syringes for filling and mixing insulin and subcutaneous injection, but also incorporates a sharps injury prevention (automatic needle retraction) and reuse prevention (auto disable) feature. The sharps injury prevention feature allows for automatic and full retraction of the needle into the syringe barrel immediately after the full dose has been expelled; where the rate of retraction may be controlled by the user. The reuse prevention feature also engages immediately after retraction, which prevents further movement of the plunger in either direction.
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