CardioCel Closure Cardiovascular Patch C0614C

GUDID 09348992000631

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 ID09348992000631
NIH Device Record Key1ada9309-bac3-479e-be0c-e319daaf979c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioCel Closure Cardiovascular Patch
Version Model NumberUC0614C
Catalog NumberC0614C
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

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
GS109348992000631 [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 Date2020-04-24
Device Publish Date2020-04-16

Devices Manufactured by ADMEDUS REGEN PTY LTD

09348992000006 - CardioCel2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000013 - CardioCel2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000020 - CardioCel2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000037 - CardioCel 2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP tech
09348992000082 - CardioCel2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000105 - CardioCel VSD2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000143 - CardioCel Neo2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn
09348992000150 - CardioCel Neo2021-02-05 The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP techn

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