FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE VIABAHN VBX Balloon Expandable Endo
DI: 00733132658435
·
Model: BXB063901A
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE VIABAHN VBX Balloon Expandable Endo
- Primary DI
- 00733132658435
- Version / Model
- BXB063901A
- Catalog Number
- BXB063901A
- 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
- 2023-12-11
- Public Version
- 1
- Public Version Date
- 2023-12-19
- Public Version Status
- New
- Public Device Record Key
- c86f7d8f-57b2-4faa-bbc2-49bac23147a5
Device Description
BX2 HEP REDUCED PROFILE BX2 6MMX39MM 6Fr 80CM Cath
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| PRL | Iliac covered stent, arterial | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66619 | Peripheral artery endovascular stent-graft, drug-coated | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, and that includes a heparin coating intended to prevent thrombotic vessel re-narrowing; it may in addition be intended for optional implantation in the common iliac arteries which extends beyond the aortic bifurcation, or for venous implantation. It is comprised of a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft). It is percutaneously inserted to the site of implantation with a disposable delivery device which may be included with the stent-graft. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132658435 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160021 | 039 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.9 | Centimeter | |
| Catheter Gauge | 6 | French | |
| Lumen/Inner Diameter | 6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius