DEVICE: DxTerity™ TRA (00643169738997)
Device Identifier (DI) Information
DxTerity™ TRA
U6TRACK
In Commercial Distribution
MEDTRONIC, INC.
U6TRACK
In Commercial Distribution
MEDTRONIC, INC.
CATH U6TRACK DXT 6F 5PK 100CM TRACK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
10688 | Angiographic catheter, single-use |
A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K161287 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light. |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 2.0 Millimeter |
Length: 100.0 Centimeter |
Catheter Gauge: 6.0 French |
Device Record Status
a590dd6b-bade-4b75-9fad-98945ff74f95
July 06, 2018
3
February 06, 2017
July 06, 2018
3
February 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20643169738991 | 5 | 00643169738997 | In Commercial Distribution | PK |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com