FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
DI: 00733132659685
·
Model: ATAA43720160A
·
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® Thoracoabdominal Branch Endoprosthesis
- Primary DI
- 00733132659685
- Version / Model
- ATAA43720160A
- Catalog Number
- ATAA43720160A
- 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
- 2024-04-25
- Public Version
- 2
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- aedb9304-05bf-4d69-afd4-b0d7eb6e06d5
Device Description
EXC TAMBE 37mmX20mmX160mm 22Fr
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 |
|---|---|---|---|---|
| QZK | Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48060 | Descending thoracic aorta endovascular stent-graft | A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132659685 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P230023 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 22 | French | |
| Length | 16 | Centimeter | |
| Lumen/Inner Diameter | 20 | Millimeter | |
| Lumen/Inner Diameter | 37 | Millimeter |