DEVICE: GORE VIABIL Biliary Endoprosthesis (00733132615490)
Device Identifier (DI) Information
GORE VIABIL Biliary Endoprosthesis
VH1008040
In Commercial Distribution
VH1008040
W. L. Gore & Associates, Inc.
VH1008040
In Commercial Distribution
VH1008040
W. L. Gore & Associates, Inc.
GORE VIABIL BILIARY ENDO 10mmX8cm 10Fr
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
43566 | Polymer-metal biliary stent, non-bioabsorbable |
A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FGE | Catheter, Biliary, Diagnostic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041423 | 000 |
K081184 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 10 French |
Length: 8 Centimeter |
Lumen/Inner Diameter: 10 Millimeter |
Device Record Status
52746442-e562-4b54-9818-9e6d7566dff0
August 29, 2023
8
March 07, 2016
August 29, 2023
8
March 07, 2016
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
[?]
8005288763
mpdcustomercare@wlgore.com
mpdcustomercare@wlgore.com