CardioCel 3D Cardiovascular Patch C0406A

GUDID 09348992000648

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 ID09348992000648
NIH Device Record Key143cfcf0-6726-4c86-8732-5a6c961f42ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel 3D Cardiovascular Patch
Version Model NumberUC0406A
Catalog NumberC0406A
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

Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree
Width4 Centimeter
Length6 Centimeter
Angle60 degree

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109348992000648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSQIntracardiac Patch Or Pledget, Biologically Derived

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

On-Brand Devices [CardioCel 3D Cardiovascular Patch]

09348992000655CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog
09348992000648CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.

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