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Devices
Device Recall Point Setter
Model / Serial
Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.
Product Description
Mitaka Point Setter, holding system for surgical instruments. || Holding surgical instruments during operating procedures.
Manufacturer
Mitaka USA, Inc.
1 Event
Recall of Device Recall Point Setter
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Manufacturer
Mitaka USA, Inc.
Manufacturer Address
Mitaka USA, Inc., 2337 Lucky John Dr, Park City UT 84060-6914
Manufacturer Parent Company (2017)
Mitaka Usa Inc.
Source
USFDA
Language
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