DEVICE: CardioCel Agile (09348992000181)

Device Identifier (DI) Information

CardioCel Agile
UC0404A
In Commercial Distribution
C0404
ADMEDUS REGEN PTY LTD
09348992000181
GS1

1
741172167 *Terms of Use
The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130872 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 4 Centimeter
Width: 4 Centimeter
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Device Record Status

be47645e-4c5c-4a3f-9cf4-4b8d1c8d6ea1
February 05, 2021
4
October 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+61892660100
info@admedus.com
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