← Back to catalogue

GORE EXCLUDER AAA Endoprosthesis

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE EXCLUDER AAA Endoprosthesis FDA UDI
Generic Name
Aortoiliac endovascular stent-graft FDA UDI
Device Name
Contralateral Leg FDA UDI
Model / Reference
PXC161400 FDA UDI
Description
Contralateral Leg FDA UDI

Identifiers

Catalog Number
PXC161400 FDA UDI
Primary DI / UDI-DI
00733132609994 FDA UDI
PMA Number
P020004 FDA UDI
FDA Product Code
MIH FDA UDI
GMDN Term
Aortoiliac endovascular stent-graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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 — 13.5 Centimeter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI

GORE EXCLUDER AAA Endoprosthesis by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P020004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 86e21440-b406-4e12-9c46-418167fa6e0e 38 fields · synced Jun 1, 2026