ORTHOASCENT, LLC

GUDID#

ASCENT FLEXXPRP - The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
ORTHOASCENT, LLC
2026-01-05
ASCENT FLEXXBMC - The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
ORTHOASCENT, LLC
2026-01-05
ASCENT FLEXXPRP - The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.
ORTHOASCENT, LLC
2026-01-05
ASCENT FLEXXBMC - The FG-002 Bone Marrow Concentrate (BMC) Device is a single-use, sterile concentrating device. It concentrates autologous bone marrow aspirate using a centrifuge.
ORTHOASCENT, LLC
2026-01-05
BMC Device Masterpack - The BMC Device Master Pack is a corrugated container that is composed of the following: 1 case of 8 FG-002 BMC Devices1 QA-LBL-004 BMC Device IFU8 FG-005 BMC Draw Kits8 FG-006 BMC Processing Kits
ORTHOASCENT, LLC
2026-01-05