PERCEVAL S

GUDID 08022057014733

SORIN GROUP ITALIA SRL

Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable
Primary Device ID08022057014733
NIH Device Record Key734c549d-7e0c-4e8f-b221-6eabcc01c1b5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERCEVAL S
Version Model NumberICV1219
Company DUNS428011907
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108022057014733 [Primary]

FDA Product Code

DTISIZER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


[08022057014733]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-12
Device Publish Date2021-04-02

On-Brand Devices [PERCEVAL S]

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

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