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.
00873263002308
GS1

1
108179458 *Terms of Use
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
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological stereotaxic Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092562 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

355f3efb-6f0e-4aed-b4fe-90f3619a8ff2
July 06, 2018
3
September 17, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)326-2905
fhcinc@fh-co.com
CLOSE