SOLO SMART

GUDID 00896208000481

Livanova Canada Corp

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID00896208000481
NIH Device Record Keyac0d63e0-5337-417b-bd98-97cf6f519dc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLO SMART
Version Model NumberARTSMT
Company DUNS243661431
Company NameLivanova Canada Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896208000481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2014-09-19

On-Brand Devices [SOLO SMART]

00896208000498ARTSMT
00896208000481ARTSMT
00896208000474ARTSMT
00896208000467ARTSMT

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