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GORE EXCLUDER AAA Endoprosthesis with C3 Delivery

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE EXCLUDER AAA Endoprosthesis with C3 Delivery FDA UDI
Generic Name
Aortoiliac endovascular stent-graft FDA UDI
Model / Reference
RMT311417 FDA UDI

Identifiers

Primary DI / UDI-DI
00733132610761 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
Outer Diameter — 31 Millimeter FDA UDI
Outer Diameter — 14.5 Millimeter FDA UDI
Length — 17 Centimeter FDA UDI
Height — .5 Millimeter FDA UDI

GORE EXCLUDER AAA Endoprosthesis with C3 Delivery 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

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 65a51b71-511c-44c7-bd2b-718341eaed9c 36 fields · synced Jun 8, 2026