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Devices
NUCLEUS COCHLEAR IMPLANT SYSTEM
Model / Serial
Part No. Z-50100.
Product Classification
Ear, Nose, and Throat Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.
Product Description
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Manufacturer
Cochlear Americas Inc.
1 Event
Recall of NUCLEUS COCHLEAR IMPLANT SYSTEM
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Manufacturer
Cochlear Americas Inc.
Manufacturer Address
Cochlear Americas Inc., 13059 E Peakview Ave, Englewood CO 80111-6511
Manufacturer Parent Company (2017)
Cochlear Ltd.
Source
USFDA
One device with a similar name
Learn more about the data
here
Nucleus Cochlear Implant System
Model / Serial
CI512 - Z209051; CI513 - Z110048; CI551- Z246605; CI541- Z246604 | All unimplanted
Product Description
AIMD: Cochlear implant system
Manufacturer
Cochlear Ltd.
Language
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