microTargeting™ Insertion Tube Set 66-IT-11P

GUDID 10873263008017

microTargeting™ Single Electrode Insertion Tube Set with Bullet Tip Stylet at target, 1x, Sterile. Contains: IT(BP11) Insertion Tube – 219mm tube length, 1.83mm od, 1.6mm id PT(JN11) Protective Tube - 1.27mm od, .84mm id

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 10873263008017
• NIH Device Record Key: 8df65930-d152-411c-b9f2-ae6db7b066af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Insertion Tube Set
• Version Model Number: 66-IT-11P-00801
• Catalog Number: 66-IT-11P
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008010 [Primary]
GS1	10873263008017 [Package]; Contains: 00873263008010; 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

[10873263008017]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-02
• Device Publish Date: 2019-07-25

On-Brand Devices [microTargeting™ Insertion Tube Set]

• 00873263004609: microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile Contains: IT(BP2): Insertio
• 00873263004579: microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile, for use with microTargeting
• 10873263004514: microTargeting Single Electrode Insertion Tube Set, Sterile, for use with microTargeting Platfor
• 00873263004425: microTargeting Single Electrode Insertion Tube Set 1x, 20mm above target, nonsterile. Contains
• 10873263004323: microTargeting Single Electrode Insertion Tube Set, Sterile, for use with Stereotactic Frame.
• 00873263004302: microTargeting Single Electrode Insertion Tube Set, nonsterile, 15mm above target. Contains:
• 10873263004217: microTargeting Single Electrode Insertion Tube Set, 1x, Sterile, 15mm above target. Contains:
• 00873263004203: microTargeting Single Electrode Insertion Tube Set, nonsterile, at target. Contains: IT(BP8)
• 10873263004125: microTargeting Single Electrode Insertion Tube Set, Sterile, at target. Contains: IT(BP8): I
• 00873263004104: microTargeting Single Electrode Insertion Tube Set, nonsterile, 30mm above target. Contains:
• 10873263004057: microTargeting Single Electrode Insertion Tube Set, Sterile, 30mm from target. Contains: IT(
• 00873263003893: microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile, 10mm from target. Contains
• 00873263003558: microTargeting Array Electrode Insertion Tube Set, nonsterile. For use with mT Drive and stereo
• 10873263003012: microTargeting Tandem Insertion Tube Set, Sterile, 20mm above target, for use with Stereotactic
• 10873263002961: microTargeting Single Electrode Insertion Tube Set, Sterile, 10mm above target, for use with Nex
• 00873263002230: microTargeting Array Insertion Tube Set, for use with Nexframe and mT Drive, nonsterile. Conta
• 00873263001523: microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2
• 00873263001301: microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2
• 10873263001148: microTargeting Single electrode insertion tube set, sterile, 5x, 20mm above target. Contains:
• 10873263007638: microTargeting Single electrode insertion tube set, sterile, 5x, 20mm above target. Contains:
• 00873263007594: microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2
• 10873263008017: microTargeting™ Single Electrode Insertion Tube Set with Bullet Tip Stylet at target, 1x, Ster
• 00873263008966: microTargeting Single electrode insertion tube set, sterile, 5x, 20mm above target. Contains: IT
• 00873263008935: microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6
• 00873263008928: microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2),