Insertion Tube 66-IT-40L

GUDID 00873263008515

D.Zap Single Insertion-Used in KTF1001, not sold individually

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 00873263008515
• NIH Device Record Key: 4bb614d8-4211-428d-8a7b-8edcdd572856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insertion Tube
• Version Model Number: 66-IT-40L-00851
• Catalog Number: 66-IT-40L
• 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 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius
• Handling Environment Humidity: Between 0 Degrees Celsius and 95 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033173

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

[00873263008515]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-06
• Device Publish Date: 2022-03-29

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• 00873263009413 - microTargeting™ Electrode: 2025-05-29 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263008690 - Nexframe: 2025-05-08 Bilateral Nexframe System for Medtronic StealthStation Navigation Systems
• 00873263008706 - NEXDRIVE™ w/DIG: 2025-05-08 MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
• 00873263008713 - NEXDRIVE™: 2025-05-08 MI-2000 NEXDRIVE™ Micropositioning Drive
• 00873263008720 - Nexprobe®: 2025-05-08 NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation System
• 00873263008904 - microTargeting™ Single Procedure Kit: 2025-05-08 microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tu