CARBOMEDICS CARBO-SEAL VALSALVA

GUDID 08022057013576

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Primary Device ID08022057013576
NIH Device Record Key0303dcfa-9b18-4896-b310-b2c0e850c400
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS CARBO-SEAL VALSALVA
Version Model NumberCP
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 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
GS108022057013576 [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 CARBO-SEAL VALSALVA]

08022057013576CP
08022057013569CP
08022057013552CP
08022057013545CP
08022057013538CP

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