microTargeting™ Stylet 66-IT(ST14)

GUDID 00873263004760

microTargeting Puncturing Stylet, nonsterile

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 00873263004760
• NIH Device Record Key: de05a5ac-4120-4b3a-b050-a089b342dcd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Stylet
• Version Model Number: 66-IT(ST14)-00476
• Catalog Number: 66-IT(ST14)
• 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: 204 Millimeter
• Length: 204 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	00873263004760 [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

[00873263004760]

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™ Stylet]

• 00873263007112: microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive
• 00873263004760: microTargeting Puncturing Stylet, nonsterile
• 00873263002438: microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive
• 10873263002374: microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive
• 10873263008222: microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive
• 00873263008256: microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive
• 10873263008246: microTargeting DP Stylet, for use with mT Drive and STar Drive