microTargeting™ STar™ Insertion Tube Set 70-IT-7107

GUDID 10873263002336

microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(AR22): Insertion Tube - 126mm tube length, 1.83mm od, .97mm id. (does not enter brain) IT(AR23): Insertion Tube with stylet - 208mm tube length, .60mm id

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263002336
• NIH Device Record Key: 4a09ff7c-fc1b-4386-b753-f9eebd92e3a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Insertion Tube Set
• Version Model Number: 70-IT-7107-00233
• Catalog Number: 70-IT-7107
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263002339 [Primary]
GS1	10873263002336 [Package]; Contains: 00873263002339; Package: PK/5 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10873263002336]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ STar™ Insertion Tube Set]

• 10873263002336: microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar
• 10873263001230: microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexfram
• 10873263007683: microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexfram