CARBOMEDICS REDUCED

GUDID 08022057012807

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID08022057012807
NIH Device Record Key2314fd6c-d081-4b6e-bf61-4ea4228493f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS REDUCED
Version Model NumberR5
Company DUNS428011907
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS108022057012807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWQHEART-VALVE, MECHANICAL

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 Date2014-07-23

On-Brand Devices [CARBOMEDICS REDUCED]

08022057012814R5
08022057012807R5
08022057012791R5
08022057012784R5
08022057012777R5
08022057012760R5

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