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
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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
- 4
- Public Version Date
- 2024-12-11
- 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 implantation within the left subclavian artery, in connection to a parent endovascular stent-graft (not included) implanted in the aortic arch, to allow unrestricted blood flow. It includes an animal-derived heparin surface to prevent thrombosis; it is not intended to be implanted without the parent stent-graft. It is typically made of a metal alloy that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). 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 |