DEVICE: microTargeting™ STar™ Insertion Tube (10873263001216)
Device Identifier (DI) Information
microTargeting™ STar™ Insertion Tube
FC9001-00121
Not in Commercial Distribution
FC9001
FHC, INC.
FC9001-00121
Not in Commercial Distribution
FC9001
FHC, INC.
microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive.
Each Kit Contains:
IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain)
IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092562 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4fcfe124-3a0d-4cad-a5e2-0dba9f889670
January 10, 2023
5
August 22, 2016
January 10, 2023
5
August 22, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00873263001219
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com