microTargeting™ Insertion Tube 66-IT-MR3

GUDID 10873263008031

microTargeting MR Lead Insertion Tube with Ceramic Stylet, nonsterile

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 10873263008031
• NIH Device Record Key: 2aa49e47-5373-446c-89fd-8bee38fe3f21
• Commercial Distribution Discontinuation: 2020-01-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Insertion Tube
• Version Model Number: 66-IT-MR3-00803
• Catalog Number: 66-IT-MR3
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 211.85 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008034 [Unit of Use]
GS1	10873263008031 [Primary]

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: false

[10873263008031]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-07
• Device Publish Date: 2019-08-14

On-Brand Devices [microTargeting™ Insertion Tube]

• 10873263007034: microTargeting Insertion Tube with Stylet, Sterile
• 00873263006979: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263006658: microTargeting™ Tandem Insertion Tube, nonsterile
• 00873263006641: microTargeting™ Tandem Insertion Tube, nonsterile
• 00873263006634: microTargeting™ Tandem Insertion Tube, nonsterile
• 10873263006204: microTargeting Sterotactic Frame Insertion Tube Set, 5X Contains: IT(BP13): Insertion Tube -
• 10873263005696: microTargeting Single Electrode Insertion Tube Set, Sterile, 25mm above target, for use with Ste
• 10873263003999: microTargeting Lead Insertion Tube with stylet, Sterile, for use with Stereotactic System
• 10873263003975: microTargeting Lead Insertion Tube, 28cm, sterile
• 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.
• 10873263003593: microTargeting Insertion Tube with Stylet, Sterile
• 10873263003463: microTargeting Array Insertion Tube with stylet, 5x, Sterile, for use with microTargeting Drive
• 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
• 10873263003067: microTargeting Insertion Tube with Stylet, Sterile
• 00873263002940: microTargeting Lesion Electrode Insertion Tube with Depth Stop, nonsterile
• 10873263002312: microTargeting Lead Insertion Tube with Stylet, Sterile, for use with Nexframe and STar Drive
• 00873263002148: microTargeting Insertion Tube with Stylet, nonsterile
• 10873263001223: microTargeting Array Lead Insertion Tube with Stylet, 5x, Sterile, for Nexframe and STarDrive
• 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
• 10873263008581: microTargeting Insertion Tube with Stylet, 258.9mm
• 10873263009267: microTargeting™ Insertion Tube with Stylet, 74mm