CardioCel C0508

GUDID 09348992000372

CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived
Primary Device ID09348992000372
NIH Device Record Key7a41e3b2-e6b3-4082-8130-e517cfdcac40
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel
Version Model NumberUC0508
Catalog NumberC0508
Company DUNS741172167
Company NameADMEDUS REGEN PTY LTD
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com
Phone+61892660100
Emailinfo@admedus.com

Device Dimensions

Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter
Length5 Centimeter
Width8 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109348992000372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [CardioCel]

09348992000372CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000365CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000082The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p
09348992000037The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine
09348992000020The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p
09348992000013The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p
09348992000006The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p

Trademark Results [CardioCel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOCEL
CARDIOCEL
79139776 4661459 Live/Registered
Admedus Ltd
2013-09-27
CARDIOCEL
CARDIOCEL
78030317 not registered Dead/Abandoned
Osiris Therapeutics, Inc.
2000-10-12

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