FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GORE VIABAHN Endoprosthesis
DI: 00733132614516
·
Model: VBC070502
·
W. L. Gore & Associates, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE VIABAHN Endoprosthesis
- Primary DI
- 00733132614516
- Version / Model
- VBC070502
- Catalog Number
- VBC070502
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-04
- Public Version
- 8
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 5e1ab8ba-5695-4b3e-b70c-d708b5c83bb3
- Distribution End Date
- 2020-03-17
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 |
|---|---|---|---|---|
| NIP | Stent, Superficial Femoral Artery | Unknown | 3 | |
| PFV | System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47932 | Peripheral artery stent, bare-metal | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132614516 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040037 | 002 |
| P130006 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 7 | Millimeter | |
| Length | 5 | Centimeter |