CardioCel 3D Cardiovascular Patch C0405A30

GUDID 09348992000655

CardioCel® 3D 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 ID: 09348992000655
• NIH Device Record Key: 3bc37ce8-cb7c-4535-9531-2336fe2c4f2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCel 3D Cardiovascular Patch
• Version Model Number: UC0405A30
• Catalog Number: C0405A30
• Company DUNS: 741172167
• Company Name: ADMEDUS REGEN PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com
• Phone: +61892660100
• Email: info@admedus.com

Device Dimensions

• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree
• Width: 4 Centimeter
• Length: 5 Centimeter
• Angle: 30 degree

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348992000655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170951

FDA Product Code

• PSQ: Intracardiac Patch Or Pledget, Biologically Derived

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [CardioCel 3D Cardiovascular Patch]

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