33 cm Lead Insertion Tube Set 70-IT-1023

GUDID 10873263008499

33 cm Lead Insertion Tube Set, for use with microTargeting STar Drive

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

• Primary Device ID: 10873263008499
• NIH Device Record Key: 8d545127-7308-4418-9595-09e5e5aac684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 33 cm Lead Insertion Tube Set
• Version Model Number: 70-IT-1023-00849
• Catalog Number: 70-IT-1023
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008492 [Primary]
GS1	10873263008499 [Package]; Contains: 00873263008492; 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

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

[10873263008499]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [33 cm Lead Insertion Tube Set]

• 10873263008208: 33 cm Lead Insertion Tube Set, for microTargeting STar Drive
• 10873263008499: 33 cm Lead Insertion Tube Set, for use with microTargeting STar Drive