FDA-Device2015-02-04Class II
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Aesculap, Inc.
Hazard
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
Sold states
Worldwide Distribution - US Nationwide
Affected count
772
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2015Don't want to check this manually?
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