GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name: GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral FDA UDI
Generic Name: Aortoiliac endovascular stent-graft FDA UDI
Device Name: EXCLUDER CONFORM AAA TRNK ENDO 36mmX14.5mmX14cm 18Fr FDA UDI
Model / Reference: CXT361414 FDA UDI
Description: EXCLUDER CONFORM AAA TRNK ENDO 36mmX14.5mmX14cm 18Fr FDA UDI

Identifiers

Catalog Number: CXT361414 FDA UDI
Primary DI / UDI-DI: 00733132651078 FDA UDI
PMA Number: P200030 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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: Lumen/Inner Diameter — 36 Millimeter FDA UDI
Length — 14 Centimeter FDA UDI
Catheter Gauge — 18 French FDA UDI
Outer Diameter — 14.5 Millimeter FDA UDI

Category: Aortoiliac endovascular stent-graft

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

Similar devices

Also classified as Aortoiliac endovascular stent-graft.

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Zenith Renu — COOK INCORPORATED · Class III
Endurant® II — MEDTRONIC, INC. · Class III
Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
Zenith Renu — COOK INCORPORATED · Class III

Cleared under the same submission

P200030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: W. L. Gore & Associates, Inc

Sources (1)

FDA UDI cf240c69-9be5-4c43-a3ad-04fd87134f4a 37 fields · synced May 31, 2026