Eclipse PRP, Tropocells 26754E

GUDID 07290015874328

ESTAR TECHNOLOGIES LTD

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID07290015874328
NIH Device Record Key69633576-b435-40d0-bfd6-913cc6c3b704
Commercial Distribution StatusIn Commercial Distribution
Brand NameEclipse PRP, Tropocells
Version Model Number26754E
Catalog Number26754E
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
GS107290015874328 [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 Date2016-10-18

On-Brand Devices [Eclipse PRP, Tropocells]

0729001587432826754E
07290015874304ESTBN18100E

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