DEVICE: CardioCel 3D (09348992000549)
Device Identifier (DI) Information
CardioCel 3D
UC0406A
In Commercial Distribution
C0406A
ADMEDUS REGEN PTY LTD
UC0406A
In Commercial Distribution
C0406A
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K170951 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Angle: 60 degree |
Length: 6 Centimeter |
Width: 4 Centimeter |
Device Record Status
50e9ad89-b498-4858-baa0-21165f339122
February 05, 2021
2
March 21, 2019
February 05, 2021
2
March 21, 2019
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 |
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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