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 00812337020039 XCM Biologic® Tissue Matrix 30010-03 XM106.0204S 2015-09-17 00812337020046 XCM Biologic® Tissue Matrix 30010-04 XM106.0307S 2015-09-17 00812337020060 XCM Biologic® Tissue Matrix 30010-06 XM106.0407S 2015-09-17 00812337020084 XCM Biologic® Tissue Matrix 30010-08 XM106.0416S 2015-09-17 00812337020091 XCM Biologic® Tissue Matrix 30010-09 XM106.0420S 2015-09-17 00812337020114 XCM Biologic® Tissue Matrix 30010-11 XM106.0516S 2015-09-17 00812337020138 XCM Biologic® Tissue Matrix 30010-13 XM106.0612S 2015-09-17 00812337020145 XCM Biologic® Tissue Matrix 30010-14 XM106.0616S 2015-09-17 00812337020152 XCM Biologic® Tissue Matrix 30010-15 XM106.0620S 2015-09-17 00812337020190 XCM Biologic® Tissue Matrix 30010-19 XM106.0812S 2015-09-17 00812337020206 XCM Biologic® Tissue Matrix 30010-20 XM106.0816S 2015-09-17 00812337020213 XCM Biologic® Tissue Matrix 30010-21 XM106.0820S 2015-09-17 00812337020220 XCM Biologic® Tissue Matrix 30010-22 XM106.1016S 2015-09-17 00812337020237 XCM Biologic® Tissue Matrix 30010-23 XM106.1020S 2015-09-17 00812337020251 XCM Biologic® Tissue Matrix 30010-25 XM106.1220S 2015-09-17 00812337020268 XCM Biologic® Tissue Matrix 30010-26 XM106.1620S 2015-09-17 00812337020299 XCM Biologic® Tissue Matrix 30010-29 XM106.1625S 2015-09-17 00812337020305 XCM Biologic® Tissue Matrix 30010-30 XM106.2020S 2015-09-17 00812337020312 XCM Biologic® Tissue Matrix 30010-31 XM106.2025S 2015-09-17 00812337020329 XCM Biologic® Tissue Matrix 30010-32 XM106.2030S 2015-09-17
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