DEVICE: GORE TAG Thoracic Branch Endoprosthesis (00733132654321)
Device Identifier (DI) Information
GORE TAG Thoracic Branch Endoprosthesis
TE3742A
In Commercial Distribution
TE3742A
W. L. Gore & Associates, Inc.
TE3742A
In Commercial Distribution
TE3742A
W. L. Gore & Associates, Inc.
TAG TBE THORACIC AORTIC EXT 37mmX4.2cm 5mm
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? |
---|---|---|---|---|
63144 | Aortic arch endovascular stent-graft extender |
A non-bioabsorbable tubular device intended to be implanted within the aortic arch between the left subclavian artery and the left common carotid artery to increase the length of a parent aortic arch endovascular stent-graft during vascular lesion repair. It is typically short in length and made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It is not intended to be implanted in isolation and not intended to cross aortic arch branch vessels. It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MIH | System, Endovascular Graft, Aortic Aneurysm Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P210032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 24 French |
Length: 4.19 Centimeter |
Lumen/Inner Diameter: 37 Millimeter |
Device Record Status
bd0dadb5-c355-44c3-9d43-d93b70ec5c53
August 29, 2023
2
June 27, 2022
August 29, 2023
2
June 27, 2022
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