CardioCel Cardiovascular Patch C0404

GUDID 09348992000594

CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived
Primary Device ID09348992000594
NIH Device Record Keyf1aec9f2-84b1-42a1-a819-4beb2cfcf122
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel Cardiovascular Patch
Version Model NumberUC0404
Catalog NumberC0404
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

Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 Centimeter
Length4 Centimeter
Width4 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
GS109348992000594 [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 Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [CardioCel Cardiovascular Patch]

09348992000617CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000587CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
09348992000594CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.

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