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510(k) Data Aggregation
K Number
K042907Device Name
NEEDLE INCAPACITATOR (NEEDLE GUARD)
Manufacturer
Date Cleared
2004-12-22
(62 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
PDMP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard. The device is for use by health care professionals in hospitals and private practices research a laboratories, specialized medicines applications, clinics, nursing homes, home care and a laboratories, specialized medically applications, childes, thereases and exchange programs, dental offices, veterinarians, mortuaries.
Device Description
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
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