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510(k) Data Aggregation
K Number
K120641Device Name
GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
Manufacturer
Date Cleared
2012-10-17
(229 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL MEDI PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Global Medi Products Retractable Safety Syringe is a sterile, single use, disposable and non-reusable manual retractable safety syringe intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse.
Device Description
The GMP Retractable Safety Syringe are always provided with preassembled needs whereas the DuoProSS can be ordered with and without needles. GMP Retractable Safety Syringe currently uses a male luer lock needle connector design where the DuoProSS uses a luer slip ne connector design. Both syringes are provided sterile, single use, and disposable. There are minor differences between the GMP Retractable Safety Syringe and DuoProSS which is syringe volume (and associated dimensions). Both syringes have two part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break of the plunger rod, and discard the pieces.
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