DEVICE: GORE-TEX Soft Tissue Patch (00733132600571)
Device Identifier (DI) Information
GORE-TEX Soft Tissue Patch
140501001B
In Commercial Distribution
140501001B
W. L. Gore & Associates, Inc.
140501001B
In Commercial Distribution
140501001B
W. L. Gore & Associates, Inc.
GORE-TEX SOFT TISSUE PATCH 5.0cmX10.0cmX1.0mm
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable |
An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTL | Mesh, Surgical, Polymeric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K963619 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 5 Centimeter |
Length: 10 Centimeter |
Height: 1 Millimeter |
Device Record Status
f9ecce35-b847-47eb-b1b7-819d8739adf6
December 25, 2023
10
January 26, 2017
December 25, 2023
10
January 26, 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