Identity
- Trade Name
- Endurant® II FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- STENT GRAFT ETBF3616C166E ENDUR II BIF FDA UDI
- Model / Reference
- ETBF3616C166E FDA UDI
- Description
- STENT GRAFT ETBF3616C166E ENDUR II BIF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000306199 FDA UDI
- PMA Number
- P100021 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Aortoiliac endovascular stent-graft
Endurant® II by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P100021 also covers:
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
- Endurant® II — MEDTRONIC, INC.
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 45cd234c-5999-4f0f-8189-53d5ac9028f4 37 fields · synced Jun 8, 2026