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510(k) Data Aggregation
K Number
K960641Device Name
RECAP-1
Manufacturer
Date Cleared
1996-05-17
(93 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDSCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Recap-1 is used following OSHA guidelines to safely recap conventional needles prior to transport to an authorized sharps container in order to minimize the possibility of accidental needlesticks from occurring, after the injection procedure has been completed.
The device would be used in all healthcare environments to protect healthcare workers and patients from needlesticks after the injection process has taken place.
Device Description
Recap-1 is 3"x4"x4.5" made of red pigmented ABS plastic weighing 6.5 ounces. The faceplate has 5 precise apertures to accommodate a majority of needles and their corresponding caps that are in the healthcare market today. It is labeled Recap-1, onehanded needle recapper. The five apertures identify by name the different types of needles that can be resheathed. Below the apertures it is stated "Do Not Use 2 Hands" thus conforming with OSHA guidelines and 29 CFR Part 1910.1030.
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