FDA.reportPublic FDA data

Haematological concentrate system

Definition
An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, 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.
GUDID devices
103
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850034511214ProGen PRP EclipseBimini Technologies LLCPROGEN-A152023-01-04
00850034511313Healeon HD PRPBimini Technologies LLCHDPRP152022-02-17
00850034511412Healeon HD PRPBimini Technologies LLCHDPRP302022-02-17
00850034511450ProGen PRP EclipseBimini Technologies LLCPROGEN-A302023-01-04
00850034511566ProGen PRP AdvantageBimini Technologies LLCPROGEN-A152022-01-31
00850034511573ProGen PRP AdvantageBimini Technologies LLCPROGEN-A302022-01-31
00850034511580MedGeneRx PRPBimini Technologies LLCHEALPRP302022-02-17
00850034511597MedGeneRx PRPBimini Technologies LLCHEALPRP152022-02-17
00850034511948Gold Rush PRPBimini Technologies LLC530101-12024-03-28
00850034511962Gold Rush PRPBimini Technologies LLC530102-12024-03-28
00850083564001MARGENIXBahia Medical Inc.MARG12026-04-03
00850083564025MARGENIXBahia Medical Inc.MARG22026-04-03
00850083564049GoldrushBahia Medical Inc.5301012026-04-03
00850083564056GoldrushBahia Medical Inc.5301002026-04-03
00850083564063GenesisBahia Medical Inc.HEALPRP152026-04-03
00860012982103Illuminate PRPGALE FORCE AESTHETICS, LLCILLU-PRP-222025-02-12
06974621793044LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT12023-06-05
06974621793051LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT22023-06-05
06974621793068LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT32023-06-05
06974621793075LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT42023-06-05
06974621793082LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT202023-06-05
06974621793099LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT12023-06-05
06974621793105LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT22023-06-05
06974621793112LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT32023-06-05
08809410200046Dr.PRPRmedica Co.,LtdDr.PRP-302026-02-02
D742IS1100IntraSpinINTRA-LOCK INTERNATIONAL, INC.IS1102017-02-08
D742IS2200IntraSpinINTRA-LOCK INTERNATIONAL, INC.IS2202017-02-08
D742ISD1100IntraSpinINTRA-LOCK INTERNATIONAL, INC.ISD1102017-02-08
D742ISD2200IntraSpinINTRA-LOCK INTERNATIONAL, INC.ISD2202017-02-08
D742ISS1100IntraSpinINTRA-LOCK INTERNATIONAL, INC.ISS1102017-02-08
D742ISS2200IntraSpinINTRA-LOCK INTERNATIONAL, INC.ISS2202017-02-08
M686CYC120020Cyclone Concentrating SystemALLIANCE PARTNERS LLCCYC-120-022018-05-01
M686CYC60020Cyclone Concentrating SystemALLIANCE PARTNERS LLCCYC-60-022018-05-01
M686CYCP60020Cyclone Platelet Rich Plasma (PRP) Concentrating SystemALLIANCE PARTNERS LLCCYCP-60-022018-04-06
08809410200053Dr.PRPRmedica Co.,LtdDr.PRP-302026-02-02
G668FG0160BMC Device MasterpackORTHOASCENT, LLCFG-016 BMC Device Masterpack2026-01-05
06974621793334LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdPRP102025-06-06
06974621793341LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdPRP152025-06-06
06974621793358LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdPRP202025-06-06
06974621793365LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdPRP252025-06-06
06974621793372LT Tube for PRPZhuhai Longtime Biological Technology Co., LtdPRP302025-06-06
10860012982100Illuminate PRPGALE FORCE AESTHETICS, LLCILLU-PRP-222025-02-12
00850034511955Gold Rush PRPBimini Technologies LLC530101-12024-03-28
00850034511979Gold Rush PRPBimini Technologies LLC530102-12024-03-28
16974621793041LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT12023-06-05
16974621793058LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT22023-06-05
16974621793065LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT32023-06-05
16974621793072LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT42023-06-05
16974621793089LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd10GT202023-06-05
16974621793096LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT12023-06-05
16974621793102LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT22023-06-05
16974621793119LT Tube for PRPZhuhai Longtime Biological Technology Co., Ltd30GT32023-06-05
00850034511221ProGen PRP EclipseBimini Technologies LLCPROGEN-A152023-01-04
00850034511474ProGen PRP EclipseBimini Technologies LLCPROGEN-A302023-01-04
00850034511405Healeon HD PRPBimini Technologies LLCHDPRP302022-02-17
00850034511429MedGeneRx PRPBimini Technologies LLCHEALPRP152022-02-17
00850034511443MedGeneRx PRPBimini Technologies LLCHEALPRP302022-02-17
00850034511498GENESIS PRP 15mL Concentrating SystemBimini Technologies LLCHEALPRP152022-02-17
00850034511832GENESIS PRP 30mL Concentrating SystemBimini Technologies LLCHEALPRP302022-02-17
10850034511310Healeon HD PRPBimini Technologies LLCHDPRP152022-02-17
00850034511535ProGen PRP AdvantageBimini Technologies LLCPROGEN-A152022-01-31
00850034511559ProGen PRP AdvantageBimini Technologies LLCPROGEN-A302022-01-31
00847236018511BiohorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPXBZ2021-09-13
00847236016036BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCLPRF1102021-04-05
00847236016043BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCLPRF2202021-04-05
00847236015923BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCBDTRKZ2021-02-09
00847236015978BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCCTRZ2021-02-09
00847236015831BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCBFUSE110Z2021-01-11
00847236015848BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCBFUSE220Z2021-01-11
00847236015855BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCBHEXZ2021-01-11
B73810071Maximus Processing System Blood PRP KitHolding Technologies, LLC10072021-01-04
00847236015817BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCIS110Z2020-10-07
00847236015824BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCIS220Z2020-10-07
D742CTR0Xpression BoxINTRA-LOCK INTERNATIONAL, INC.CTR2017-02-08
D742BFUSE1101IntraSpinINTRA-LOCK INTERNATIONAL, INC.BFUSE1102019-10-22
D742BFUSE2201IntraSpinINTRA-LOCK INTERNATIONAL, INC.BFUSE2202019-10-22
D742BHEX1IntraSpinINTRA-LOCK INTERNATIONAL, INC.BHEX2019-09-19
D742BPOWER1101IntraSpinINTRA-LOCK INTERNATIONAL, INC.BPOWER1102019-09-19
D742BPOWER2201IntraSpinINTRA-LOCK INTERNATIONAL, INC.BPOWER2202019-09-19
D742BROTOR1IntraSpinINTRA-LOCK INTERNATIONAL, INC.BROTOR2019-09-19