DEVICE: CardioCel Cardiovascular Patch (09348992000587)
Device Identifier (DI) Information
CardioCel Cardiovascular Patch
UC0202
In Commercial Distribution
C0202
ADMEDUS REGEN PTY LTD
UC0202
In Commercial Distribution
C0202
ADMEDUS REGEN PTY LTD
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35273 | Cardiovascular patch, animal-derived |
An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130872 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 2 Centimeter |
Width: 2 Centimeter |
Device Record Status
fc3d22a5-b847-4ddd-b5e4-db46fabccdf1
February 05, 2021
2
April 16, 2020
February 05, 2021
2
April 16, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61892660100
info@admedus.com
info@admedus.com