CardioCel Neo C0508

GUDID 09348992000457

CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in

ADMEDUS REGEN PTY LTD

Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived Cardiovascular patch, animal-derived

• Primary Device ID: 09348992000457
• NIH Device Record Key: 92c7c85c-01fd-41e6-8619-ef177ff03a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioCel Neo
• Version Model Number: UC0508N
• Catalog Number: C0508
• 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

• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter
• Length: 5 Centimeter
• Width: 8 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348992000457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130872

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [CardioCel Neo]

• 09348992000457: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
• 09348992000440: CardioCel® is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.
• 09348992000150: The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p
• 09348992000143: The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine p