FDA.reportPublic FDA data

Cellenis®

Primary DI
07290015874489
Brand
Cellenis®
Company
ESTAR TECHNOLOGIES LTD
Model
C_EXOME10U
Catalog number
C_EXOME10U
Device description
Kit contains : 1. 20ml Syringes*1 2.22ml PRP tube 3.10ml Syringes*3 4.Purifier filter*1 5.Disk filter*1 6.Female to Female connector *2 7.Sharp needle 16G*2 8.CombiStopper*1 9.Vented Needles*2 10.Blood collection set*1
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015874489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015874489072900158744897290015874489

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
Radiation Sterilization

Regulatory Flags#

DUNS number
600278550
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
07290015874137Tropocells14992905GLA14992905GLA2016-10-19
07290015874229Tropocells1253VTSF101253VTSF102016-10-18
07290015874304Eclipse PRP, TropocellsESTBN18100EESTBN18100E2016-10-18
07290015874311TropocellsESTSN1690ESTSN16902016-10-19
07290015874328Eclipse PRP, Tropocells26754E26754E2016-10-18
07290015874359Tropocells521254US521254US2016-10-20