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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, piston, reprocessed
Definition A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNKN
Regulation Number 880.5860
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

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