microTargeting™ Depth Stop FC8013

GUDID 00873263008355

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

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263008355
• NIH Device Record Key: 04fe7b83-9b2b-4cb2-b310-eace0dc160c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Depth Stop
• Version Model Number: FC8013-00835
• 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: true
• 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008355 [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

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

[00873263008355]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

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