PERCEVAL S

GUDID 08022057014825

SORIN GROUP ITALIA SRL

Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter Self-expandable heart valve prosthesis post-dilation balloon catheter
Primary Device ID08022057014825
NIH Device Record Key5ab1e4df-b77f-4e8f-9fcc-bf1a45e0482e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERCEVAL S
Version Model NumberICV1234
Company DUNS428011907
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS108022057014825 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-07-04
Device Publish Date2016-06-06

On-Brand Devices [PERCEVAL S]

18022057015034ICV1268
08022057014849ICV1236
08022057014832ICV1235
08022057014887ICV1245
08022057014870ICV1244
08022057014863ICV1243
08022057014856ICV1242
08022057014733ICV1219
08022057014979ICV1241
08022057014825ICV1234
08022057014795ICV1218
08022057014788ICV1217
08022057014771ICV1216
08022057014337ICV1170
08022057014252ICV1149
08022057014245ICV1148

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