FDA UDI
In Commercial Distribution
🇺🇸 United States
Gore TIPS Needle
DI: 05391526210000
·
Model: TNDL1656
·
CREGANNA UNLIMITED COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gore TIPS Needle
- Primary DI
- 05391526210000
- Version / Model
- TNDL1656
- Catalog Number
- TNDL1656
- Company Name
- CREGANNA UNLIMITED COMPANY
- Labeler DUNS
- 985218606
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 8775bdd8-1da8-4c81-80ab-4475d18e2ba1
Device Description
Gore TIPS Needle
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62455 | Portosystemic needle set | A collection of devices which includes a portosystemic needle intended to create an artificial passage between the hepatic and portal veins (through the liver parenchyma) as part of a transjugular intrahepatic portosystemic shunt (TIPS) procedure. It includes a rigid/semi-rigid metal portosystemic needle, a vascular guide catheter, and might include the initial percutaneous vascular introduction devices (e.g., sheath, dilator); neither a balloon catheter nor a shunt is included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391526210000 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 16 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool place