Vanguard, CSC 14 and HSC

GUDID 08033178101622

SORIN GROUP ITALIA SRL

Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp
Primary Device ID08033178101622
NIH Device Record Key1fa42d55-fddb-4027-ad70-63e0ece95278
Commercial Distribution StatusIn Commercial Distribution
Brand NameVanguard, CSC 14 and HSC
Version Model NumberHolder
Company DUNS442126587
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 Datetrue
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
GS108033178101622 [Primary]

FDA Product Code

KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-01
Device Publish Date2023-10-24

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38033178018716 - Suction tip2024-04-12
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