DEVICE: microTargeting™ Insertion Tube with Stylet (00873263008676)

Device Identifier (DI) Information

microTargeting™ Insertion Tube with Stylet
66-IT-AO11P-00867
In Commercial Distribution
66-IT-AO11P
FHC, INC.
00873263008676
GS1

1
108179458 *Terms of Use
microTargeting Insertion Tube with Stylet, Sterile
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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?
62753 Intracerebral cannula, nonimplantable, single-use
A sterile, 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 single-use device.
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
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

bc2811e6-e065-4399-9fc0-9980ca96a299
December 28, 2022
1
December 20, 2022
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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
10873263008673 5 00873263008676 In Commercial Distribution Pk/5
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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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