Home GUDID M263G00001K0 Genius Concentration System
Primary DI M263G00001K0
Brand Genius Concentration System
Company DSM BIOMEDICAL, INC.
Model 64002-09
Catalog number G00001
Device description Centrifuge
Published 2016-12-22
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ORG Platelet And Plasma Separator For Bone Graft Handling
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ORG Platelet And Plasma Separator For Bone Graft Handling Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M263G000010 Direct Marking HIBCC 0 M263G00001K0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haematological concentrate system centrifuge An electrically-powered device typically intended to be used at the point-of-care to concentrate platelets or bone marrow aspirate cells from a small volume of autologous (patient's own) blood/bone marrow using centrifugal force, for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may additionally have refrigeration capabilities to perform temperature-sensitive procedures.
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