DEVICE: GLIDECATH (04987350776853)

Device Identifier (DI) Information

GLIDECATH
CG519
In Commercial Distribution
RF*XG95107A
TERUMO CORPORATION
04987350776853
GS1

1
690543319 *Terms of Use
RADIFOCUS GLIDECATH
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
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: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Max Guide Wire O.D. : .038" (0.97mm)
Pressure: 6895 KiloPascal
Device Size Text, specify: Hydrophilic Coating Length : 25cm
Length: 70 Centimeter
Outer Diameter: 1.70 Millimeter
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Device Record Status

7ca886ef-9536-45ea-a381-7382320cecc4
March 29, 2018
2
September 09, 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
34987350776854 3 04987350776853 In Commercial Distribution Shelfbox
54987350776858 5 34987350776854 In Commercial Distribution Carton
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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
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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