DEVICE: OPTITORQUE (04987350700148)

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Device Identifier (DI) Information

OPTITORQUE
40-5040
RH*5SL3500A
TERUMO CORPORATION
04987350700148
GS1
1
RADIFOCUS OPTITORQUE Angiographic Catheter
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Device Characteristics

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

GMDN

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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

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Product Code Product Code Name
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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

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Size Type Text
Pressure: 6895 KiloPascal
Outer Diameter: 1.70 Millimeter
Device Size Text, specify: Max Guide Wire O.D. : .038" (0.97mm)
Length: 100 Centimeter
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Device Status

In Commercial Distribution
September 09, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
34987350700149 5 04987350700148 In Commercial Distribution Shelfbox
54987350700143 5 34987350700149 In Commercial Distribution Carton
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Secondary DI

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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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