CardioCel 3D C0405A30

GUDID 09348992000334

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: 09348992000334
• NIH Device Record Key: a6a92888-642e-488e-b8d7-4ca5902fd135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCel 3D
• 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: true
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348992000334 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2018-09-07

On-Brand Devices [CardioCel 3D]

• 09348992000549: CardioCel is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. T
• 09348992000358: CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog
• 09348992000334: CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog
• 09348992000327: CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technolog
• 09348992000280: UC0406A