DEVICE: ProxiCor for Cardiac Tissue Repair (00859389005041)
Device Identifier (DI) Information
ProxiCor for Cardiac Tissue Repair
CMCV-064-401
In Commercial Distribution
Elutia Med LLC
CMCV-064-401
In Commercial Distribution
Elutia Med LLC
ProxiCor for Cardiac Tissue Repair is indicated for use as an intracardiac patch or pledget for tissue repair and suture-line buttressing.
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 |
---|---|
DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K063349 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 7 Centimeter |
Height: 10 Centimeter |
Device Record Status
ee66fc18-1bb5-4ba3-a107-39a8644ea9db
September 24, 2024
7
June 30, 2015
September 24, 2024
7
June 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10859389005048 | 5 | 00859389005041 | 2018-12-31 | Not in Commercial Distribution | Box |
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
[?]
470-514-4080
xxx@xx.xx
xxx@xx.xx