microTargeting™ Spacer Tube 66-PT(JN11)

GUDID 00873263002629

microTargeting Spacer Tube, nonsterile, for use with IT(BP11)

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 00873263002629
• NIH Device Record Key: 711e6c09-e3be-4213-92cb-e04400ff351f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Spacer Tube
• Version Model Number: 66-PT(JN11)-00262
• Catalog Number: 66-PT(JN11)
• 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

• Outer Diameter: 1.57 Millimeter
• Outer Diameter: 1.57 Millimeter
• Outer Diameter: 1.57 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	00873263002629 [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

[00873263002629]

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: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ Spacer Tube]

• 00873263006986: microTargeting™ Spacer Tube, nonsterile, for use with 66-IT(IT1)
• 00873263004616: microTargeting IT(AR2) Spacer Tube, nonsterile
• 00873263002865: microTargeting Spacer Tube, nonsterile, for use with IT(BP5)
• 00873263002803: microTargeting Spacer Tube, nonsterile, for use with IT(BP7)
• 00873263002766: microTargeting Spacer Tube, nonsterile, for use with 66-IT(DB1)
• 00873263002742: microTargeting Spacer Tube, nonsterile, for use with IT(DB2)
• 00873263002704: microTargeting Spacer Tube, nonsterile, for use with IT(DB3)
• 00873263002681: microTargeting Spacer Tube, nonsterile, for use with IT(DB7)
• 00873263002667: microTargeting Tandem Protective Tube, nonsterile
• 00873263002629: microTargeting Spacer Tube, nonsterile, for use with IT(BP11)
• 00873263002551: microTargeting Spacer Tube, nonsterile, for use with IT(DB4)
• 00873263002537: microTargeting Spacer Tube, nonsterile, for use with AR(34)
• 00873263002513: microTargeting Spacer Tube, nonsterile, for use with IT(AR35)
• 00873263002476: microTargeting Spacer Tube, nonsterile, for use with IT(AR38)