FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE VIABAHN Endoprosthesis with Heparin
DI: 00733132646005
·
Model: VBHR091502A
·
W. L. Gore & Associates, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GORE VIABAHN Endoprosthesis with Heparin
- Primary DI
- 00733132646005
- Version / Model
- VBHR091502A
- Catalog Number
- VBHR091502A
- 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
- 2019-08-16
- Public Version
- 6
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 7d9c9e2d-7bc4-4b44-a1e8-25d6b1d85b44
Device Description
GORE VIABAHN Endoprosthesis with Heparin 9mmx15cm 8Fr 120cmCath
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 |
|---|---|---|---|---|
| PFV | System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | Unknown | 3 | |
| NIP | Stent, Superficial Femoral Artery | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66619 | Peripheral artery endovascular stent-graft, drug-coated | A non-bioabsorbable tubular implantable device intended to maintain patency and improve luminal diameter of a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries), and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal arteries), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132646005 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040037 | 123 |
| P130006 | 062 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 120 | Centimeter | |
| Catheter Gauge | 8 | French | |
| Length | 15 | Centimeter | |
| Lumen/Inner Diameter | 9 | Millimeter |