PERCEVAL PLUS PVF-S

GUDID 08022057015365

SUTURELESS AORTIC HEART VALVE

CORCYM SRL

Aortic heart valve bioprosthesis
Primary Device ID08022057015365
NIH Device Record Key9669c2fe-da3e-40f4-9f2e-90ac034ffac7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERCEVAL PLUS
Version Model NumberPVF-S
Catalog NumberPVF-S
Company DUNS441454802
Company NameCORCYM SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
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
GS108022057015365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRHeart-Valve, Non-Allograft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

On-Brand Devices [PERCEVAL PLUS]

08022057015396SUTURELESS AORTIC HEART VALVE
08022057015389SUTURELESS AORTIC HEART VALVE
08022057015372SUTURELESS AORTIC HEART VALVE
08022057015365SUTURELESS AORTIC HEART VALVE

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