DEVICE: CardiaMend (00850023375063)
Device Identifier (DI) Information
CardiaMend
CMUS-10NS-0812
In Commercial Distribution
CMUS-10NS-0812
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution
CMUS-10NS-0812
Helios Cardio Inc.
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K210331 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Special Storage Condition, Specify: Keep Away from Excessive Heat |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 8 Centimeter |
Width: 12 Centimeter |
Height: 1.0 Millimeter |
Device Record Status
0d34bd57-0829-43a2-bd3c-f5689c5f1231
December 21, 2022
1
December 13, 2022
December 21, 2022
1
December 13, 2022
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
[?]
1-339-707-7788
support@helioscardio.com
support@helioscardio.com