DEVICE: Gore TIPS Needle (05391526210000)

Download: XML | JSON

Device Identifier (DI) Information

Gore TIPS Needle
TNDL1656
TNDL1656
CREGANNA UNLIMITED COMPANY
05391526210000
GS1
1
Gore TIPS Needle
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Portosystemic needle set A collection of sterile 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 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DYB Introducer, Catheter
GBZ Catheter, Cholangiography
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool place
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 16 Gauge
CLOSE

Device Status

In Commercial Distribution
September 23, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE