microTargeting™ Depth Stop FC8013

GUDID 00873263006337

Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263006337
• NIH Device Record Key: 0e15e155-e77f-490e-8c02-9a81fed50084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Depth Stop
• Version Model Number: FC8013-00633
• Catalog Number: FC8013
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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

Device Dimensions

• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter
• Lumen/Inner Diameter: 1.8 Millimeter

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	00873263006337 [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

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

[00873263006337]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-05

On-Brand Devices [microTargeting™ Depth Stop]

• 00873263006344: Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems
• 00873263006337: Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems
• 00873263005149: Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems
• 00873263008355: Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems