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510(k) Data Aggregation
K Number
K070117Device Name
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
Manufacturer
Date Cleared
2007-08-06
(206 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
DOLOMITE BIOTECH SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.
Device Description
The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated:
1. completely retracts and encloses the needle in the barrel thereby preventing finger access
2. renders the needle unusable again as it is crushed within the puncture resistant barrel.
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