FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE TAG Thoracic Branch Endoprosthesis
DI: 00733132654413
·
Model: TSB121706A
·
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
- 00733132654413
- Version / Model
- TSB121706A
- Catalog Number
- TSB121706A
- 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
- 3
- Public Version Date
- 2024-03-01
- Public Version Status
- Update
- Public Device Record Key
- 4730b9fd-d869-4dbf-9f9a-4b24dd4ce0fe
Device Description
TAG TBE THORACIC SIDE BRANCH 17mmX6cm 12mm Heparin
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 62571 | Aortic arch branch vessel endovascular stent-graft, drug-coated | A non-bioabsorbable tubular device intended for endovascular implantation within the left subclavian artery to allow unrestricted blood flow to the aortic arch branch vessel during implantation of an endovascular stent-graft within the aortic arch; it includes an animal-derived heparin surface to prevent thrombosis. It is typically made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is intended to be attached to the parent endovascular stent-graft (not included). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable implantation devices may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132654413 | 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 | 14 | French | |
| Length | 6 | Centimeter | |
| Lumen/Inner Diameter | 12 | Millimeter | |
| Lumen/Inner Diameter | 17 | Millimeter |