FDA.reportPublic FDA data

TropoCells

Primary DI
07290015874267
Brand
TropoCells
Company
ESTAR TECHNOLOGIES LTD
Model
ESTDF0.22US_d33
Catalog number
ESTDF0.22US_d33
Device description
Liquid Filter 0.22um housing diameter 33mm
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
07290015874267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015874267072900158742677290015874267

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of 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 includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. 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. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
600278550
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07290015874137Tropocells14992905GLA14992905GLA2016-10-19
07290015874229Tropocells1253VTSF101253VTSF102016-10-18
07290015874304Eclipse PRP, TropocellsESTBN18100EESTBN18100E2016-10-18
07290015874311TropocellsESTSN1690ESTSN16902016-10-19
07290015874328Eclipse PRP, Tropocells26754E26754E2016-10-18
07290015874359Tropocells521254US521254US2016-10-20
07290015874373Tropocells52FF52FF2016-10-20