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AFX Endovascular AAA System

FDA UDI

Class III (US FDA UDI)

by Endologix LLC

Identity

Trade Name
AFX Endovascular AAA System FDA UDI
Generic Name
Aortoiliac endovascular stent-graft FDA UDI
Model / Reference
BA22-40/I16-40 FDA UDI

Identifiers

Primary DI / UDI-DI
00818009013958 FDA UDI
PMA Number
P040002 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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

AFX Endovascular AAA System by Endologix LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P040002 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endologix LLC

Sources (1)

  • FDA UDI bd348d2b-fede-409e-b821-f772285deb18 36 fields · synced May 31, 2026