CARBOMEDICS STANDARD

GUDID 08022057012593

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID08022057012593
NIH Device Record Keyebf74223-e8b5-4854-86a6-ff389ac8d882
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS STANDARD
Version Model NumberA5
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
GS108022057012593 [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 STANDARD]

08022057012753M7
08022057012746M7
08022057012739M7
08022057012722M7
08022057012715M7
08022057012708M7
08022057012692M7
08022057012685M7
08022057012678M7
08022057012661A5
08022057012654A5
08022057012647A5
08022057012630A5
08022057012623A5
08022057012616A5
08022057012609A5
08022057012593A5
08022057012586A5

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