Home GUDID M263G000010 Genius Concentration System
Primary DI M263G000010
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 In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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.
Regulatory Flags# DUNS number 131107757 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M263W25000 WizardBio Resorbable Calcium Phosphate Cement 21004-05 W25000 2019-01-02 00812337020442 Drillable Bone Void Filler 21005-03 07.705.003S 2023-01-11 00812337020459 Drillable Bone Void Filler 21005-05 07.705.005S 2023-01-11 00812337020466 Drillable Bone Void Filler 21005-10 07.705.010S 2023-01-11 M26300110301005 CopiOs® Bone Void Filler Sponge 20101-02 00-1103-010-05 2015-09-17 M26300110301010 CopiOs® Bone Void Filler Sponge 20101-03 00-1103-010-10 2015-09-17 M26300110302001 CopiOs® Bone Void Filler Paste 20102-01 00-1103-020-01 2015-09-17 M26300110302005 CopiOs® Bone Void Filler Paste 20102-02 00-1103-020-05 2015-09-17 M26300110302010 CopiOs® Bone Void Filler Paste 20102-03 00-1103-020-10 2015-09-17 M2630011301001 CopiOs® Bone Void Filler Sponge 20101-01 00-1103-010-01 2015-09-17 M2630700582001 CopiOs® Bone Void Filler Sponge 20100-01 07.00582.001 2015-09-17 M2630700582003 CopiOs® Bone Void Filler Sponge 20100-02 07.00582.003 2015-09-17 M2630700582004 CopiOs® Bone Void Filler Sponge 20100-03 07.00582.004 2015-09-17 00812337020435 BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc 21003-04 ABS-3101 2023-05-09 M263300700402 DSM Biomedical Dental Bone Graft 30070-04 2021-10-20 M263300700503 DSM Biomedical Dental Bone Graft 30070-05 2021-10-20 M263300700604 DSM Biomedical Dental Bone Graft 30070-06 2021-10-20 M263300700705 DSM Biomedical Dental Bone Graft 30070-07 2021-10-20 M263300700806 DSM Biomedical Dental Bone Graft 30070-08 2021-10-20 M263300700907 DSM Biomedical Dental Bone Graft 30070-09 2021-10-20
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