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Manufacturers
Gyrus ACMI, Inc.
Manufacturer Address
Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett TN 38133-3901
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA
1 Event
Recall of Gyrus ACMI Round Cutting Burrs
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One device in the database
Gyrus ACMI Round Cutting Burrs
Model / Serial
Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
Product Classification
Ear, Nose, and Throat Devices
Device Class
1
Implanted device?
No
Distribution
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Product Description
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
2 manufacturers with a similar name
Learn more about the data
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Gyrus ACMI, Inc.
Manufacturer Parent Company (2017)
Olympus Corporation
Source
SMPA
Gyrus ACMI, Inc.
Manufacturer Parent Company (2017)
Olympus Corporation
Source
DMA
Language
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