CARBOMEDICS SUPRA-ANNULAR (TOP HAT)

GUDID 08022057012937

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID08022057012937
NIH Device Record Key27911022-abf4-4198-8258-b0f08d240872
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS SUPRA-ANNULAR (TOP HAT)
Version Model NumberS5
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
GS108022057012937 [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 SUPRA-ANNULAR (TOP HAT)]

08022057012937S5
08022057012920S5
08022057012913S5
08022057012906S5
08022057012890S5

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