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510(k) Data Aggregation
K Number
K041232Device Name
GETTIG UNIVERSAL VIAL ACCESS PIN
Manufacturer
Date Cleared
2004-07-22
(73 days)
Product Code
Regulation Number
880.5440Why 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
K033409Device Name
AMERSHAM HEALTH NEEDLE-GUARD
Manufacturer
Date Cleared
2004-01-21
(89 days)
Product Code
Regulation Number
880.5570Why 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 Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal.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
K022495Device Name
GETTIG DISPOSABLE SYRINGES
Manufacturer
Date Cleared
2002-10-08
(71 days)
Product Code
Regulation Number
880.5860Why 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
K000455Device Name
GETTIG GUARD
Manufacturer
Date Cleared
2000-04-19
(68 days)
Product Code
Regulation Number
880.5570Why 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
K972285Device Name
GETTIG STYRL-JECT DELIVERY SYSTEM
Manufacturer
Date Cleared
1997-09-11
(84 days)
Product Code
Regulation Number
872.6770Why 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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