Device Dossier
Haematological concentrate system
Device Dossier for Haematological concentrate system (Haematological concentrate system, Class IIa, sponsor Avaderm). ARTG record, intended purpose, GMDN…
- GMDN category: Haematological concentrate system
Intended purpose
PRX TUBES is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma/injectable platelet-rich fibrin from a small sample of blood without the addition of anticoagulant at the patient’s point of care. The platelet-rich plasma/ injectable platelet-rich fibrin is prepared prior to application to a local area of soft tissue or hard tissue (including bone) site as deemed necessary by the clinical use requirements. And its intended use is for the application of autologous platelet concentrates in order to achieve the stimulation of soft tissue and hard tissue (including bone) and acceleration of soft tissue and hard tissue (including bone) healing.