microTargeting™ Insertion Tube with Stylet 66-IT-AR21P

GUDID 10873263005832

microTargeting Insertion Tube with Stylet, Sterile

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263005832
• NIH Device Record Key: 52247282-4cd4-407a-9ce4-82808b9aac42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Insertion Tube with Stylet
• Version Model Number: 66-IT-AR21P-00583
• Catalog Number: 66-IT-AR21P
• 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

• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 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	00873263005835 [Primary]
GS1	10873263005832 [Package]; Contains: 00873263005835; 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

[10873263005832]

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: 2017-03-10

On-Brand Devices [microTargeting™ Insertion Tube with Stylet]

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• 00873263006481: microTargeting™ Insertion Tube with Stylet, nonsterile
• 00873263006474: microTargeting™ Insertion Tube with Stylet, nonsterile
• 00873263005866: microTargeting Insertion Tube with Bullet Nosed Stylet, nonsterile
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• 10873263005849: microTargeting Insertion Tube with Stylet, Sterile
• 10873263005832: microTargeting Insertion Tube with Stylet, Sterile
• 00873263005682: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005675: microTargeting Insertion Tube with Stylet, nonsterile
• 10873263005405: microTargeting Insertion Tube with Stylet, Sterile
• 00873263005316: microTargeting Insertion Tube with Stylet, nonsterile
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• 00873263005279: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005262: microTargeting Tandem Insertion Tube, nonsterile
• 00873263005248: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005231: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005224: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005217: microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive
• 00873263005163: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005156: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005125: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005118: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005101: microTargeting Insertion Tube with Stylet, nonsterile
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• 00873263005071: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005064: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005033: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005026: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005019: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263005002: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004999: microTargeting Insertion Tube with two Stylets, nonsterile
• 00873263004982: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004975: microTargeting STar Array Insertion Tube with Stylet, nonsterile
• 00873263004968: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004951: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004944: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004937: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004890: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004876: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004852: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004845: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004814: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004807: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004791: microTargeting Insertion Tube, nonsterile
• 00873263004784: microTargeting Insertion Tube with Stylet, nonsterile
• 00873263004746: microTargeting Insertion Tube with Stylet, nonsterile