DEVICE: GORE-TEX Cardiovascular Patch (00733132600724)
Device Identifier (DI) Information
GORE-TEX Cardiovascular Patch
1803006004
In Commercial Distribution
1803006004
W. L. Gore & Associates, Inc.
1803006004
In Commercial Distribution
1803006004
W. L. Gore & Associates, Inc.
GORE-TEX CARDIOVASCULAR PATCH 3.0cmX6.0cmX0.4mm
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? |
---|---|---|---|---|
31744 | Cardiovascular patch, synthetic |
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 non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).
|
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 [?] |
---|---|
K912107 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: .4 Millimeter |
Length: 6.0 Centimeter |
Width: 3.0 Centimeter |
Device Record Status
f482420b-2b9f-4359-9926-2e086422c425
December 25, 2023
7
January 27, 2017
December 25, 2023
7
January 27, 2017
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
[?]
800-528-8763
mpdcustomercare@wlgore.com
mpdcustomercare@wlgore.com