CARBOMEDICS OPTIFORM

GUDID 08022057012821

SORIN GROUP ITALIA SRL

Mitral bi-leaflet mechanical heart valve prosthesis
Primary Device ID08022057012821
NIH Device Record Keye65738de-b24f-46b2-bf26-356b471b8767
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS OPTIFORM
Version Model NumberF7
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
GS108022057012821 [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 OPTIFORM]

08022057012883F7
08022057012876F7
08022057012869F7
08022057012852F7
08022057012845F7
08022057012838F7
08022057012821F7

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