DEVICE: CardiaMend (00850023375063)

Device Identifier (DI) Information

CardiaMend
CMUS-10NS-0812
In Commercial Distribution
CMUS-10NS-0812
Helios Cardio Inc.
00850023375063
GS1

1
117912350 *Terms of Use
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
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Device Characteristics

MR Safe
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
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FDA Product Code

[?]
Product Code Product Code Name
PSQ Intracardiac Patch Or Pledget, Biologically Derived
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K210331 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep Away from Excessive Heat
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Clinically Relevant Size

[?]
Size Type Text
Length: 8 Centimeter
Width: 12 Centimeter
Height: 1.0 Millimeter
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Device Record Status

0d34bd57-0829-43a2-bd3c-f5689c5f1231
December 21, 2022
1
December 13, 2022
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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
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Secondary DI

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

[?]
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
No
No CLOSE

Customer Contact

[?]
1-339-707-7788
support@helioscardio.com
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