DEVICE: microTargeting™ Insertion Tube (10873263001131)

Device Identifier (DI) Information

microTargeting™ Insertion Tube
FC1019-00113
Not in Commercial Distribution
FC1019
FHC, INC.
10873263001131
GS1
January 10, 2023
5
108179458 *Terms of Use
microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar and MT Drive
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Device Characteristics

MR Unsafe
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?
61964 Intracerebral cannula, implantable
A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological stereotaxic Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011775 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 1.6 Millimeter
Length: 243.5 Millimeter
Outer Diameter: 1.83 Millimeter
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Device Record Status

2c7a93c0-ffa4-4150-a25d-9ace3e89667c
January 10, 2023
5
August 22, 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
No Package DIs found
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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: 00873263001134 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)326-2905
fhcinc@fh-co.com
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