Mitroflow Aortic Handle

GUDID 00896208000078

Livanova Canada Corp

Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle
Primary Device ID00896208000078
NIH Device Record Key53405747-ab4b-4e28-b920-2a4e1b9e42ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMitroflow Aortic Handle
Version Model NumberAH-11
Company DUNS243661431
Company NameLivanova Canada Corp
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
GS100896208000078 [Primary]

FDA Product Code

DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


[00896208000078]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-16
Device Publish Date2021-04-08

Devices Manufactured by Livanova Canada Corp

00896208000078 - Mitroflow Aortic Handle2021-04-16
00896208000078 - Mitroflow Aortic Handle2021-04-16
00896208000214 - Mitroflow Accessory Tray2021-04-16
08022057014924 - MITROFLOW VALSALVA CONDUIT2021-02-05
08022057014931 - MITROFLOW VALSALVA CONDUIT2021-02-05
08022057014948 - MITROFLOW VALSALVA CONDUIT2021-02-05
08022057014955 - MITROFLOW VALSALVA CONDUIT2021-02-05
00896208000092 - MITROFLOW2021-02-05
00896208000108 - MITROFLOW2021-02-05

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