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510(k) Data Aggregation
K Number
K091736Device Name
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
Manufacturer
Date Cleared
2009-10-30
(141 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
DANIELS CORPORATION PTY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sharpsmart™ S2 disposable sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps. This device is intended for "Over-the-Counter" use.
Device Description
The Sharpsmart™ S2 disposable sharps container is intended to be used in patient rooms, medication rooms, operating rooms, physicians' offices or any other patient care area requiring the use of a sharps container. It is a two-piece injection-molded container made from a polypropylene copolymer. The container is designed with a closure mechanism that allows multiple lid re-openings, while ensuring secure between uses. Both handle and lid can be secured out of the way for safe, unobstructed disposal of sharps. The S2 container is capable of standalone use. A Unique bracket design is offered as an additional measure to secure mounting on vertical or horizontal surfaces to prevent toppling. The bracket is not required for the use of the container. It only offers a secondary option for the user for ease of use.
The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red or yellow. The label is white and red with the biohazard warning.
Sharpsmart™ S2 disposable sharps containers are available in a 1 quart size. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space.
The container is designed and certified to comply with penetration requirements, as represented though product testing for Test methods: AS/NZS 4031:1992 and Test Method: roprosence and the Transport of Dangerous Goods. 15th revised Ed. 6.1.5.3The Sharpsmart™ S2 disposable sharps containers meet or exceed OSHA recommendations for sharps containers.
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