microTargeting™ Drive Accessories Kit 66-AC-KT

GUDID 00873263004913

Accessories kit for microTargeting(TM) Drive Contains: 2, .5" Thumbknob 2, .75" Thumbknob 1, .375" Thumbknob 4, #4-40, 1/8" set screw 2, #6-32, 1/8" set screw

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263004913
• NIH Device Record Key: 5cda30cd-dd72-482f-a48b-7d4e1066d35d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Drive Accessories Kit
• Version Model Number: 66-AC-KT-00491
• Catalog Number: 66-AC-KT
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263004913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

[00873263004913]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;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

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• 10873263009243 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263009253 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
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• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version
• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only
• 00873263002193 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame