DEVICE: DxTerity™ TRA (00643169738577)

Device Identifier (DI) Information

DxTerity™ TRA
U6TRAP40SH
In Commercial Distribution

MEDTRONIC, INC.
00643169738577
GS1

1
006261481 *Terms of Use
CATH U6TRAP40SH DXT 6F 5PK 100CM TRP40
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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
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.
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FDA Product Code

[?]
Product Code Product Code Name
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2.0 Millimeter
Catheter Gauge: 6.0 French
Length: 100.0 Centimeter
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Device Record Status

fdb7663b-dd50-4c22-93a2-3911d3cf4c59
March 29, 2018
2
February 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20643169738571 5 00643169738577 In Commercial Distribution PK
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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