CardioCel C0202

GUDID 09348992000006

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 ID09348992000006
NIH Device Record Key702aef31-fa16-464e-8327-45c389785000
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel
Version Model NumberUC0202
Catalog NumberC0202
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

Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 Centimeter
Width2 Centimeter
Length2 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
GS109348992000006 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.