CardioCel C0614

GUDID 09348992000037

The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, light yellow to beige coloured, moist, pre-cut, flat sheet of acellular collagen.

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived
Primary Device ID09348992000037
NIH Device Record Keyd5d4930b-7e50-41f1-99ea-d1572619f966
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel
Version Model NumberUC0614
Catalog NumberC0614
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 Batchfalse
Serial Numbertrue
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

Device Dimensions

Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 Centimeter
Width14 Centimeter
Length6 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

Device Identifiers

Device Issuing AgencyDevice ID
GS109348992000037 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-09-17

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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