microTargeting™ Electrode Insertion Tube Set 66-IT-01P

GUDID 10873263004637

microTargeting Single Electrode Insertion Tube Set, sterile, 40mm above target. Contains: IT(BP2) Insertion Tube - 179mm tube length, 1.83mm OD, 1.6mm ID. PT(BP2) Protective Tube - 1.47mm OD, .99mm ID.

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263004637
• NIH Device Record Key: 18b57027-a52c-47fc-98e4-22d03ce1036c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode Insertion Tube Set
• Version Model Number: 66-IT-01P-00463
• Catalog Number: 66-IT-01P
• 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: 40 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	00873263004630 [Primary]
GS1	10873263004637 [Package]; Contains: 00873263004630; 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

[10873263004637]

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

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

• 00873263004739: microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile. Contains: IT(BP2): Inser
• 10873263004637: microTargeting Single Electrode Insertion Tube Set, sterile, 40mm above target. Contains: IT