microTargeting™ Insertion Tube 66-IT-4000

GUDID 10873263003708

microTargeting Single Electrode Insertion Tube Set, Sterile, for use with Nexframe and Nexdrive. Contains: IT(DB3): Insertion Tube - 191.6mm tube length, 1.83mm od, 1.6mm id PT(DB3): Protective Tube - 0.58mm id

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263003708
• NIH Device Record Key: 34080b28-dd49-4308-86ee-218687ba76fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Insertion Tube
• Version Model Number: 66-IT-4000-00370
• Catalog Number: 66-IT-4000
• 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

• Outer Diameter: 1.83 Millimeter
• Outer Diameter: 1.83 Millimeter
• Outer Diameter: 1.83 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	00873263003701 [Primary]
GS1	10873263003708 [Package]; Contains: 00873263003701; 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

[10873263003708]

Moist Heat or Steam Sterilization;Ethylene Oxide

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

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• 00873263006641: microTargeting™ Tandem Insertion Tube, nonsterile
• 00873263006634: microTargeting™ Tandem Insertion Tube, nonsterile
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• 10873263003852: microTargeting Single Electrode Insertion Tube Set, Sterile, 10mm above target, for use with Ste
• 10873263003814: microTargeting Single Electrode Insertion Tube Set, Sterile, for use with Nexframe and mT Drive.
• 10873263003708: microTargeting Single Electrode Insertion Tube Set, Sterile, for use with Nexframe and Nexdrive.
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• 10873263003425: microTargeting Lead Insertion Tube with Stylet, Sterile, for use with Stereotactic Frame
• 10873263003326: microTargeting Single Insertion Tube with Stylet, Sterile, for use with Stereotactic Frame
• 10873263003289: microTargeting Single Insertion Tube with Stylet, 10mm above target, Sterile
• 10873263003272: microTargeting Single Insertion Tube with Stylet, Sterile, at target, for use with Nexframe and
• 10873263003210: microTargeting Single Insertion Tube with Stylet, Sterile, for use with STar Drive and Nexframe
• 00873263003114: microTargeting Insertion Tube, nonsterile
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• 10873263001186: microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT
• 10873263001131: microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar a
• 10873263001124: microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 5x for use with mT Drive
• 10873263008031: microTargeting MR Lead Insertion Tube with Ceramic Stylet, nonsterile
• 10873263008079: microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, non-st
• 10873263007676: microTargeting Array Lead Insertion Tube with Stylet, 5x, Sterile, for Nexframe and STarDrive
• 10873263007621: microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar a
• 10873263007645: microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT
• 10873263007614: microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 5x for use with mT Drive
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