CARBOMEDICS CARBO-SEAL

GUDID 08022057013491

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Primary Device ID08022057013491
NIH Device Record Keyfdcb624d-7a72-46ff-9673-766924ff2fa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS CARBO-SEAL
Version Model NumberAP
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
GS108022057013491 [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]

08022057013521AP
08022057013514AP
08022057013507AP
08022057013491AP
08022057013484AP
08022057013477AP
08022057013460AP

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