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510(k) Data Aggregation

    K Number
    K041232
    Device Name
    GETTIG UNIVERSAL VIAL ACCESS PIN
    Date Cleared
    2004-07-22

    (73 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    GETTIG PHARMACEUTICAL INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi dose vials to inject or withdraw fluids without the use of a needle. The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.
    Device Description
    The Gettig Universal Vial Access Pin is a plastic "needle" used to pierce the diaphragm of single and multi dose vials for the injection or withdrawal of fluids. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and plastic "needle" for piercing the diaphragm. There is also a polypropylene cover for the "needle" portion.
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    K Number
    K033409
    Device Name
    AMERSHAM HEALTH NEEDLE-GUARD
    Date Cleared
    2004-01-21

    (89 days)

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

    GETTIG PHARMACEUTICAL INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.
    Device Description
    The Amersham Health Needle Guard is a sterile, single use hypodermic needle designed to be used in conjunction with a disposable 3ml synnge. The device consists of six basic constituents, a Stainless Steel needle bonded to a Nylon hub, a Polypropylene cannula cover, a Nylon Luer attachment connected to a Polysulfone Luer hub used to connect to a syringe, and a PETG Protective sleeve. Once the Amersham Health Needle Guard is attached to a syringe, the cannula cover is removed, exposing the needle. In this condition the needle can be inserted into a vial or ampule to withdraw medication into the syringe or to administer the medication through injection. Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal. The sharps safety feature is an active safety feature
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    K Number
    K022495
    Device Name
    GETTIG DISPOSABLE SYRINGES
    Date Cleared
    2002-10-08

    (71 days)

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

    GETTIG PHARMACEUTICAL INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is intended to inject fluids into, or withdraw fluids from, the body. The syringe is designed for manual use.
    Device Description
    The Gettig Disposable Syringe is a standard piston syringe. It consists of a calibrated hollow barrel and a moveable plunger. At one end of the barrel there is a male connector (nozzle) for the female connector (hub) of a hypodermic single lumen needle.
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    K Number
    K000455
    Device Name
    GETTIG GUARD
    Date Cleared
    2000-04-19

    (68 days)

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

    GETTIG PHARMACEUTICAL INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K972285
    Device Name
    GETTIG STYRL-JECT DELIVERY SYSTEM
    Date Cleared
    1997-09-11

    (84 days)

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

    GETTIG PHARMACEUTICAL INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.
    Device Description
    The Gettig Styrl-Ject® Delivery System is a sterile, single use hypodermic syringe cartridge device designed to be similar to current single use products. The device consists of two basic constituents - a previously filled glass carpule, and plastic syringe. The carpule features a plastic retainer with a frangible button. When ready to use, the carpule retainer button is snapped off, exposing the rubber diaphragm insert. Until, the button is snapped the carpule needle path remains sterile, thus eliminating the need for an alcohol swab. The plastic syringe is also sterile until ready for use via the plunger rod encapsulating the needle rear extension. After removal of the threaded plunger rod, the carpule is then inserted into the clear plastic syringe allowing the syringe needle rear extension to puncture the rubber diaphragm creating a path for medicament administration. Then the syringe plunger rod is engaged with the plunger and the cover (needle or luer) is removed, to allow aspiration and injection. The syringe can be configured for a variety of needle sizes for subcutaneous injection as well as for I.V. applications via butyl and needleless access ports.
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