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GORE TAG Conformable Thoracic Stent Graft

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE TAG Conformable Thoracic Stent Graft FDA UDI
Generic Name
Descending thoracic aorta endovascular stent-graft FDA UDI
Device Name
CTAG CMDS 28MMX28MMX15CM 20Fr FDA UDI
Model / Reference
TGM282815 FDA UDI
Description
CTAG CMDS 28MMX28MMX15CM 20Fr FDA UDI

Identifiers

Catalog Number
TGM282815 FDA UDI
Primary DI / UDI-DI
00733132646944 FDA UDI
PMA Number
P040043 FDA UDI
FDA Product Code
MIH FDA UDI
GMDN Term
Descending thoracic aorta endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI
Outer Diameter — 28 Millimeter FDA UDI

Category: Descending thoracic aorta endovascular stent-graft

GORE TAG Conformable Thoracic Stent Graft by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Descending thoracic aorta endovascular stent-graft.

Cleared under the same submission

P040043 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI ea22db22-13a3-4683-9d90-afe577c19aa3 37 fields · synced Jun 1, 2026