CardioCel Closure C0614

GUDID 09348992000495

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 ID09348992000495
NIH Device Record Key55dbb1ed-0804-4de6-900b-79a5857d9144
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel Closure
Version Model NumberUC0614C
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 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

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
Width14 Centimeter
Length6 Centimeter
Width14 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
GS109348992000495 [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 Closure]

09348992000495CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000488CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000235The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p
09348992000228The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p

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