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510(k) Data Aggregation
K Number
K955514Device Name
SHARPS SAFE 1.5 & SHARPS SAFE 2.0
Manufacturer
Date Cleared
1996-08-01
(241 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
DURA-VAC PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.
Device Description
The device is comprised of a 1.5 inch diameter plastic tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Securely attached to each end is a plastic cap. Secured inside the cap attached to the bottom end is a hard plastic disc designed to prevent needle penetration. The cap on the top end has a ¼ inch hole in the center. Radiating from the hole are slits cut in the plastic which form flaps through which a sharps can be inserted. A vinyl cover is provided for the top to provide a moisture tight seal.
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