microTargeting™ Single Electrode Insertion Tube Set 66-IT-4015

GUDID 10873263003692

microTargeting Single Electrode Insertion Tube Set, 15mm above target, for use with Nexframe and Nexdrive. Contains: IT(DB2): Insertion Tube - 196.6mm tube length, 1.83mm od, 1.6mm id PT(DB3): Protective Tube - 0.58mm id.

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263003692
• NIH Device Record Key: 93d2166b-5302-449e-9d65-a760415f93f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Single Electrode Insertion Tube Set
• Version Model Number: 66-IT-4015-00369
• Catalog Number: 66-IT-4015
• 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

Device Dimensions

• Length: 15 Millimeter

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003695 [Primary]
GS1	10873263003692 [Package]; Contains: 00873263003695; Package: PK/5 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[10873263003692]

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™ Single Electrode Insertion Tube Set]

• 00873263006214: microTargeting™ Single Electrode Insertion Tube Set, 15mm above target, for use with Nexframe
• 10873263003692: microTargeting Single Electrode Insertion Tube Set, 15mm above target, for use with Nexframe and