Devices

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
Manufacturer
Gyrus ACMI, Inc.
1 Event
- Recall of Gyrus ACMI Round Cutting Burrs

Manufacturer

Gyrus ACMI, Inc.

Manufacturer Address
Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett TN 38133-3901
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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