FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE TAG Thoracic Branch Endoprosthesis
DI: 00733132654338
·
Model: TE4043A
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE TAG Thoracic Branch Endoprosthesis
- Primary DI
- 00733132654338
- Version / Model
- TE4043A
- Catalog Number
- TE4043A
- 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
- 2022-06-27
- Public Version
- 2
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- 6b099fb7-68ce-4202-8ef2-05ceaf46244a
Device Description
TAG TBE THORACIC AORTIC EXT 40mmX4.3cm 6mm
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 |
|---|---|---|---|---|
| 63144 | Aortic arch endovascular stent-graft extender | A non-bioabsorbable tubular device intended to be implanted within the aortic arch between the left subclavian artery and the left common carotid artery to increase the length of a parent aortic arch endovascular stent-graft during vascular lesion repair. It is typically short in length and made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It is not intended to be implanted in isolation and not intended to cross aortic arch branch vessels. It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132654338 | GS1 |
Customer Contacts
- Phone
- 800-528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210032 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 26 | French | |
| Length | 4.3 | Centimeter | |
| Lumen/Inner Diameter | 40 | Millimeter |