2 results
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19ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·November 9, 2016
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 14, 2012