FDA.reportPublic FDA data

Tropocells

Primary DI
07290015874137
Brand
Tropocells
Company
ESTAR TECHNOLOGIES LTD
Model
14992905GLA
Catalog number
14992905GLA
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1100350

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1100350

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015874137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015874137072900158741377290015874137

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of sterile devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It typically includes a blood withdrawal set, tubes, and syringes. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. The glue-like product is applied to the surface of the injured tissue or bone where its adherent properties form a haemostatic barrier and enhance regeneration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97235596414Aaron@estar-medical.com

Regulatory Flags#

DUNS number
600278550
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015874267TropoCellsESTDF0.22US_d33ESTDF0.22US_d332026-01-12
07290015874236TropoCellsT_ACC11T_ACC112025-09-30
07290015874243TropoCellsT_ACC22T_ACC222025-09-30
07290015874182TropoCellsESTSTUSESTSTUS2025-02-18
07290015874168TropoCellsT_PRP11UT_PRP11U2024-02-06
07290015874175TropoCells T_PRP22UT_PRP22U2023-12-21
07290015874052TROPOCELLST_PRP11UT_PRP11U2023-10-25
17290015874202Tropocells06212SC06212SC2016-10-18
07290015874007Tropocells®, Eclipse PRP, Healeon PRP12521102GLVAS12521102GLVAS2016-10-19
07290015874014Tropocells®, Eclipse PRP, Healeon PRP12531102GLVAS12531102GLVAS2016-10-19
07290015874038Tropocells®, Eclipse PRP, Healeon PRP14522205GLVAS14522205GLVAS2016-10-19
07290015874045Tropocells®, Eclipse PRP, Healeon PRP14532205GLVAS14532205GLVAS2016-10-19
07290015874106Eclipse PRP, Tropocells, Healeon PRP12531002GLVAS12531002GLVAS2016-10-18
07290015874120Tropocells12991402GLA12991402GLA2016-10-19
07290015874229Tropocells1253VTSF101253VTSF102016-10-18
07290015874304Eclipse PRP, TropocellsESTBN18100EESTBN18100E2016-10-18
07290015874311TropocellsESTSN1690ESTSN16902016-10-19
07290015874328Eclipse PRP, Tropocells26754E26754E2016-10-18
07290015874359Tropocells521254US521254US2016-10-20
07290015874373Tropocells52FF52FF2016-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08685139210029Centrifuge Container SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-04-10
00850083564001MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564025MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564049GoldrushBahia Medical Inc.ORG2026-04-03
00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
00850075308088CER-PRP-160 STERILITY PACKRANFAC CORP.ORG2026-03-30
00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
B708XCPC120XCELLAPEX BIOLOGIX , LLCORG2026-03-26
B708XCPC60XCELLAPEX BIOLOGIX , LLCORG2026-03-26
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
00850075308095CER-PRP-SINGLE-ARANFAC CORP.ORG2025-10-08
04719875912245Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
04719875912252Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
00850075308118Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
10850075308115Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
08435389829089ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-06-03
04719875912122Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15