The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Historias - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Modelo / Serial
Lot 41925401
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
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Descripción del producto
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
- Manufacturer
- 1 Event
Fabricante
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Dirección del fabricante
TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
- Empresa matriz del fabricante (2017)
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Source
USFDA