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510(k) Data Aggregation
K Number
K123807Device Name
SHARPSCAN
Manufacturer
Date Cleared
2013-07-23
(224 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The sharpsCAN™ Model I Pint required to be used with a wall mount unit accessory is intended for single use and for the disposal of contaminated medical sharps in health care facilities. This device is not intended for areas with unsupervised patient access.
Device Description
The SharpsCAN™ is a disposable sharps container that is intended for the safe disposal of used medical sharps. This sharpsCAN™ is marketed as one model.
- sharpsCAN™ Model 1 pint,
The sharpsCAN™ container is stable, closable, puncture resistant, impact resistant, and leak-proof on both the sides and bottom. The sharpsCAN™ uses a vertical opening for the disposal of sharps and is intended to be used in an upright position during use with the required wall mount unit accessory.
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