microTargeting™ NexFrame® Insertion Tube Kit 66-IT-4015S

GUDID 10873263003685

microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(DB2): Insertion Tube - 196.6mm tube length, 1.83mm od, 1.6mm id PT(DB3): Protective Tube - 0.58mm id. Nexframe Stylet.

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263003685
• NIH Device Record Key: ffc7fc0a-b387-4b90-9bb6-c686caf5ea78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ NexFrame® Insertion Tube Kit
• Version Model Number: 66-IT-4015S-00368
• Catalog Number: 66-IT-4015S
• 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

• Length: 15 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003688 [Primary]
GS1	10873263003685 [Package]; Contains: 00873263003688; 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

[10873263003685]

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™ NexFrame® Insertion Tube Kit]

• 10873263003685: microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(DB2): Insertio
• 10873263008482: microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tu