microTargeting™ Insertion Tube Set FC1011

GUDID 00873263001301

microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One Electrode Carrier, One Shielded Electrode Carrier) depth when used with frame and Star or mT Drive is 40mm above target Individual Specifications: IT(BP2): Length=183mm, OD=1.83mm, ID=1.60mm PT(BP2): Length=181mm, OD=1.47mm, ID=0.99mm

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 00873263001301
• NIH Device Record Key: 539e3971-75cd-4933-a77f-fb3c0afec20d
• Commercial Distribution Discontinuation: 2023-01-10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Insertion Tube Set
• Version Model Number: FC1011-00130
• Catalog Number: FC1011
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001301 [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

[00873263001301]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-20
• Device Publish Date: 2016-08-22

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