DEVICE: microTargeting™ Insertion Tube with Stylet (00873263006481)

Device Identifier (DI) Information

microTargeting™ Insertion Tube with Stylet
66-IT(AO10)-00648
In Commercial Distribution
66-IT(AO10)
FHC, INC.
00873263006481
GS1

1
108179458 *Terms of Use
microTargeting™ Insertion Tube with Stylet, nonsterile
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Device Characteristics

MR Unsafe
No
No
No
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?
61854 Intracerebral cannula, nonimplantable, reusable
A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use.
Active false
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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

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
Outer Diameter: 1.83 Millimeter
Length: 175 Millimeter
Lumen/Inner Diameter: 1.6 Millimeter
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Device Record Status

7b7f9c65-99f0-47bb-8324-65b84b2faa1f
July 06, 2018
3
February 05, 2018
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
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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