CARBOMEDICS ORBIS

GUDID 08022057012579

SORIN GROUP ITALIA SRL

Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis
Primary Device ID08022057012579
NIH Device Record Key229e0039-a3a2-4d8d-aca6-dd6c2dd19bd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS ORBIS
Version Model NumberM2
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
GS108022057012579 [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 ORBIS]

08022057012579M2
08022057012562M2
08022057012555M2
08022057012548M2
08022057012531M2
08022057012524M2
08022057012517M2
08022057012500A1
08022057012494A1
08022057012487A1
08022057012470A1
08022057012463A1
08022057012456A1
08022057012449A1

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