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 Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive 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