Identity
- Trade Name
- Autoinjector 2 FDA UDI
- Generic Name
- Aortoiliac endovascular stent-graft FDA UDI
- Device Name
- "The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved." FDA UDI
- Model / Reference
- TV-AI01-N FDA UDI
- Description
- "The Autoinjector 2 is a component of the Alto™ Abdominal Stent Graft System. The Autoinjector 2 applies controlled force to the syringe plunger of the CustomSeal Kit to inject the fill polymer into the graft until pressure equilibrium is reached and complete fill of the primary sealing ring, fill channels, and support rings in the graft material the of the aortic body is achieved." FDA UDI
Identifiers
- Catalog Number
- TV-AI01-N FDA UDI
- Primary DI / UDI-DI
- 00850007370398 FDA UDI
- PMA Number
- P120006 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Aortoiliac endovascular stent-graft
Autoinjector 2 by Endologix LLC — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Aortoiliac endovascular stent-graft.
- Aorfix AAA Stent Graft Body with Aorflex Delivery System — LOMBARD MEDICAL LIMITED · Class III
- TREO Abdominal Stent-Graft System — Bolton Medical Inc. · Class III
- Endurant® II — MEDTRONIC, INC. · Class III
- Zenith Spiral-Z — COOK INCORPORATED · Class III
- 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
P120006 also covers:
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Alto™ Abdominal Stent Graft System — Endologix LLC
- Autoinjector 2 — Endologix LLC
- Ovation Prime Abdominal Stent Graft System — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
- Ovation iX Iliac Stent Graft — Endologix LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Endologix LLC
Sources (2)
- FDA UDI f440b4cd-3b3c-49b4-bf0d-8b7997accf7e 37 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026