FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE VIATORR TIPS Endoprosthesis
DI: 00733132635023
·
Model: PTB8106275
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GORE VIATORR TIPS Endoprosthesis
- Primary DI
- 00733132635023
- Version / Model
- PTB8106275
- Catalog Number
- PTB8106275
- 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
- 2016-12-13
- Public Version
- 5
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- ea2255fb-20c7-4bf4-8ae6-01f6899a378f
Device Description
VIATORR TIPS ENDO CX 8-10mmX6cm/2cm 10Fr
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 |
|---|---|---|---|---|
| MIR | Shunt, Portosystemic, Endoprosthesis | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58043 | Endoprosthetic portosystemic shunt | A device intended to be permanently implanted to create or revise a transjugular intrahepatic portosystemic shunt (TIPS), a bypass for blood made between the portal and hepatic veins of the liver delivered to the liver via percutaneous access from the jugular vein, to treat portal hypertension and its complications (e.g., bleeding varices, gastropathy, ascites, and/or hepatic hydrothorax). It is a stent-like tube typically made of metal and polymer materials [e.g., nickel-titanium alloy (Nitinol), expanded polytetrafluoroethylene (ePTFE)] that expand upon implantation. It is implanted using a catheter delivery system and is available in various diameters (e.g., 8 - 12 mm). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733132635023 | GS1 |
Customer Contacts
- Phone
- 8005288763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040027 | 048 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French | |
| Length | 2 | Centimeter | |
| Length | 6 | Centimeter | |
| Lumen/Inner Diameter | 10 | Millimeter |