FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral
DI: 00733132650996
·
Model: CXT201412
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral
- Primary DI
- 00733132650996
- Version / Model
- CXT201412
- Catalog Number
- CXT201412
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-09
- Public Version
- 7
- Public Version Date
- 2025-09-24
- Public Version Status
- Update
- Public Device Record Key
- 13490169-f00e-4613-9fac-0a199fccf8c5
Device Description
EXCLUDER CONFORM AAA TRNK ENDO 20mmX14.5mmX12cm 15Fr
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
- Yes
- 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 | 00733132650996 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200030 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 20 | Millimeter | |
| Length | 12 | Centimeter | |
| Catheter Gauge | 15 | French | |
| Outer Diameter | 14.5 | Millimeter |