DEVICE: GORE VIABIL Biliary Endoprosthesis (00733132615490)

Device Identifier (DI) Information

GORE VIABIL Biliary Endoprosthesis
VH1008040
In Commercial Distribution
VH1008040
W. L. Gore & Associates, Inc.
00733132615490
GS1

1
967358115 *Terms of Use
GORE VIABIL BILIARY ENDO 10mmX8cm 10Fr
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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
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FDA Product Code

[?]
Product Code Product Code Name
FGE Catheter, Biliary, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041423 000
K081184 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 10 French
Length: 8 Centimeter
Lumen/Inner Diameter: 10 Millimeter
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Device Record Status

52746442-e562-4b54-9818-9e6d7566dff0
August 29, 2023
8
March 07, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8005288763
mpdcustomercare@wlgore.com
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