DEVICE: microTargeting™ STar™ Insertion Tube (00873263002308)
Device Identifier (DI) Information
microTargeting™ STar™ Insertion Tube
70-IT-AR5P-00230
In Commercial Distribution
70-IT-AR5P
FHC, INC.
70-IT-AR5P-00230
In Commercial Distribution
70-IT-AR5P
FHC, INC.
microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use with microTargeting Platform.
Contains:
IT(AR18): Insertion Tube - 1.83mm od, .97mm id (does not enter brain)
IT(AR19): Insertion Tube - 186.7mm tube length, .90mm od, .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 Temperature: between 0 and 40 Degrees Celsius |
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
355f3efb-6f0e-4aed-b4fe-90f3619a8ff2
July 06, 2018
3
September 17, 2016
July 06, 2018
3
September 17, 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 |
---|---|---|---|---|---|
10873263002305 | 5 | 00873263002308 | In Commercial Distribution | PK/5 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com