DEVICE: Goodale-Lubin™ (00613994964601)

Device Identifier (DI) Information

Goodale-Lubin™
001283
In Commercial Distribution

MEDTRONIC, INC.
00613994964601
GS1

1
006261481 *Terms of Use
WVN CATH 001283 10PK 6F 80CM GOOD-LUBIN
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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
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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
Yes 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 catheters in a cool, dry area.
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 1.194 Millimeter
Catheter Gauge: 6.0 French
Length: 80.0 Centimeter
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Device Record Status

3e6e6eb4-edf2-47ac-a9d2-854cd2a79b20
March 29, 2018
2
June 05, 2016
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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
20613994964605 10 00613994964601 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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