FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE VIABIL Biliary Endoprosthesis
DI: 00733132638871
·
Model: VSWVN1008
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE VIABIL Biliary Endoprosthesis
- Primary DI
- 00733132638871
- Version / Model
- VSWVN1008
- Catalog Number
- VSWVN1008
- 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
- 2017-05-10
- Public Version
- 5
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- 118a78b9-bc6a-4d20-84fa-35195c4a64ad
Device Description
VIABIL SHORT WIRE BILIARY ENDO 10mmX8cmX200cm 8.5Fr
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 |
|---|---|---|---|---|
| FGE | Catheter, Biliary, Diagnostic | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43566 | Polymer-metal biliary stent, non-bioabsorbable | A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132638871 | GS1 |
Customer Contacts
- Phone
- 800-528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170740 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Working Length: 200 CM | ||
| Catheter Gauge | 8.5 | French | |
| Outer Diameter | 10 | Millimeter | |
| Length | 8 | Centimeter |