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510(k) Data Aggregation
K Number
K982781Device Name
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER
Manufacturer
THERMAL WASTE TECHNOLOGY, INC.
Date Cleared
1998-09-30
(54 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
THERMAL WASTE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.
Device Description
The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposable, point of generation sharps container, constructed out of tin-plated steel. The device has a friction fit lid and black foam plastisol sealant for container closure. It is designed to hold contaminated disposable sharps, such as various-sized hypodermic, intravenous syringes or other medical needles, scalpel blades, disposable knives and lancets, and broken glass such as slides, slip covers and ampoules. The device is not a secondary container.
The sharps container is a three-piece construction, one-gallon metal drum with a friction fit lid and sealant used to close the container. The minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches. The container is opaque and measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening in the center of the top of the container. The lid is 2-3/4 inches in diameter, with a thickness of .0088 inches. Lining the perimeter of the posterior side of the lid is a black foam plastisol which acts as an additional safety seal; this foam ensures a closed container. A built-in vent port, approximately 1 mm in diameter, is located on the top of the sharps container.
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