FDA UDI
In Commercial Distribution
🇺🇸 United States
AFX2 Bifurcated Endograft System
DI: 00818009014979
·
Model: BEA22-40/I20-40
·
Endologix LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AFX2 Bifurcated Endograft System
- Primary DI
- 00818009014979
- Version / Model
- BEA22-40/I20-40
- Company Name
- Endologix LLC
- Labeler DUNS
- 858560477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-01-18
- Public Version
- 12
- Public Version Date
- 2026-04-01
- Public Version Status
- Update
- Public Device Record Key
- d4ec923d-ea6c-4830-b1a7-3fc4fe840682
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46777 | Aortoiliac endovascular stent-graft | A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818009014979 | GS1 |
Customer Contacts
- Phone
- (949) 595-7200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040002 | 055 |
| P040002 | 056 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 22 mm, Main Body Diameter | ||
| Device Size Text, specify | 40 mm, Main Body Length | ||
| Device Size Text, specify | 20 mm, Limb Diameter | ||
| Device Size Text, specify | 40 mm, Limb Length |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.