FDA.reportPublic FDA data

Eclipse PRP, Tropocells, Healeon PRP

Primary DI
07290015874106
Brand
Eclipse PRP, Tropocells, Healeon PRP
Company
ESTAR TECHNOLOGIES LTD
Model
12531002GLVAS
Catalog number
12531002GLVAS
Published
2016-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015874106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015874106072900158741067290015874106

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
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