CARBOMEDICS

GUDID 08022057014016

SORIN GROUP ITALIA SRL

Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable Heart valve prosthesis holder, reusable
Primary Device ID08022057014016
NIH Device Record Key01d7ed09-f6f9-4a89-8b21-74c6b4886334
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARBOMEDICS
Version Model NumberAR-150
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 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
GS108022057014016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWQHEART-VALVE, MECHANICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


[08022057014016]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2016-06-06

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38033178113466 - KIDS2024-03-28
38033178113473 - KIDS2024-03-28
08033178101547 - Sinergy and Mini Bag CPB2023-11-01
08033178101622 - Vanguard, CSC 14 and HSC2023-11-01
08033178102292 - DAC Cardiotomy2023-11-01

Trademark Results [CARBOMEDICS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARBOMEDICS
CARBOMEDICS
76473340 2883637 Live/Registered
SORIN GROUP USA, INC.
2002-12-10
CARBOMEDICS
CARBOMEDICS
74051850 1730861 Dead/Cancelled
CARBOMEDICS, INC.
1990-04-23

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