Indications & Disclaimer
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TRU100 - Magellan® Autologous Platelet Separator 110V
TRU300 - Magellan® TruPRP™ Complete Disposable Kit TRU310 - Magellan® TruPRP™ Complete One Source Kit TRUMAR0 - Magellan® TruMAR0™ Convenience Kit FDA 510(k) Indication: BK040068
The Magellan Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, the platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site. FDA 510(k) Indication: BK030040
The Magellan Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests. The platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements. Disclaimer:
The platelet rich plasma prepared by this device has not been evaluated for any clinical indications. Platelet rich plasma prepared from a mixture of whole blood and bone marrow may contain higher levels of plasma free hemoglobin than platelet rich plasma prepared from whole blood. |
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