microTargeting™ NexFrame® Insertion Tube Kit 66-IT-4010S

GUDID 10873263008482

microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tube - 205.6mm tube length, 1.83mm od, 1.6mm id PT(KH1): Protective Tube - 0.58mm id. Nexframe Stylet.

FHC, INC.

Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 10873263008482
• NIH Device Record Key: f03178a0-49ca-45d6-8b8d-8e8c9a268893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ NexFrame® Insertion Tube Kit
• Version Model Number: 66-IT-4010S-00848
• Catalog Number: 66-IT-4010S
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008485 [Primary]
GS1	10873263008482 [Package]; Contains: 00873263008485; 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

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

[10873263008482]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-15
• Device Publish Date: 2021-12-07

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