Tropocells®, Eclipse PRP, Healeon PRP 12531102GLVAS

GUDID 07290015874014

ESTAR TECHNOLOGIES LTD

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID07290015874014
NIH Device Record Key3d4d0363-d75a-462e-86c3-467959c13d68
Commercial Distribution StatusIn Commercial Distribution
Brand NameTropocells®, Eclipse PRP, Healeon PRP
Version Model Number12531102GLVAS
Catalog Number12531102GLVAS
Company DUNS600278550
Company NameESTAR TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com
Phone+97235596414
EmailAaron@estar-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290015874014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-07
Device Publish Date2016-10-19

On-Brand Devices [Tropocells®, Eclipse PRP, Healeon PRP]

07290015874502PPK3B
0729001587404514532205GLVAS
0729001587403814522205GLVAS
0729001587401412531102GLVAS
0729001587400712521102GLVAS

Trademark Results [Tropocells]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TROPOCELLS
TROPOCELLS
79171775 4995416 Live/Registered
Estar Technologies Ltd.
2015-06-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.