GORE EXCLUDER Conf AAA Endo - Aortic Extender
- Primary DI
- 00733132650965
- Company
- W. L. Gore & Associates, Inc.
- Model
- CXA320005
- Catalog number
- CXA320005
- Device description
- EXCLUDER CONFORM AAA EXT ENDO 32mmX4.5cm 18Fr
- Published
- 2021-02-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 967358115
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00733132650965 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00733132650965 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 3 | Unknown | | Y | Ineligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P200030 | 000 | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | W. L. Gore And Associates, Inc. | 2020-12-22 | MIH |
GMDN Terms
| Term | Definition |
|---|
| Abdominal aorta 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). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is typically available in two designs: 1) a single continuous tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., shaped as a Y in a tube form) for insertion through both iliac arteries. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Gauge | 18 French | |
| Length | 4.5 Centimeter | |
| Lumen/Inner Diameter | 32 Millimeter | |
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| 8005288763 | mpdcustomercare@wlgore.com |
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| 00733132663705 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS281502A | VNS281502A | 2026-01-08 |
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| 00733132663729 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS280702A | VNS280702A | 2026-01-08 |
| 00733132663736 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS280502A | VNS280502A | 2026-01-08 |
| 00733132663743 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS241502A | VNS241502A | 2026-01-08 |
| 00733132663750 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS241002A | VNS241002A | 2026-01-08 |
| 00733132663767 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS240502A | VNS240502A | 2026-01-08 |
| 00733132663774 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS201502A | VNS201502A | 2026-01-08 |
| 00733132663781 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS201002A | VNS201002A | 2026-01-08 |
| 00733132663798 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS200702A | VNS200702A | 2026-01-08 |
| 00733132663804 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS200502A | VNS200502A | 2026-01-08 |
| 00733132663811 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS181502A | VNS181502A | 2026-01-08 |
| 00733132663828 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS181002A | VNS181002A | 2026-01-08 |
| 00733132663835 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS180702A | VNS180702A | 2026-01-08 |
| 00733132663842 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS180502A | VNS180502A | 2026-01-08 |
| 00733132663859 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS161502A | VNS161502A | 2026-01-08 |
| 00733132663866 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS161002A | VNS161002A | 2026-01-08 |
| 00733132663873 | GORE® VIABAHN® FORTEGRA Venous Stent | VNS160702A | VNS160702A | 2026-01-08 |
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