microTargeting™ Multi-Oblique Tool Guide 66-MO-08

GUDID 00873263008621

Multi-Oblique Platform 2.5mm Tool Guide (60mm), 1X

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263008621
• NIH Device Record Key: bb824aeb-f47d-4206-8931-f7a7d1cf58c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Multi-Oblique Tool Guide
• Version Model Number: 66-MO-08-00861
• Catalog Number: 66-MO-08
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00873263008614 [Primary]
GS1	00873263008621 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

[00873263008621]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-19
• Device Publish Date: 2022-08-11

On-Brand Devices [microTargeting™ Multi-Oblique Tool Guide]

• 00873263006306: Multi-Oblique Platform 2.4mm Tool Guide (60mm), 1X
• 00873263005521: Multi-Oblique Platform 2.4mm AdTech Bolt Guide
• 00873263005514: Multi-Oblique Platform 1.7mm Visualase Alignment Rod Guide
• 00873263005491: Multi-Oblique Platform 2.4mm Tool Guide
• 00873263005484: Multi-Oblique Platform 2.2mm Tool Guide
• 00873263005477: Multi-Oblique Platform 1.8mm Tool Guide
• 00873263005460: Multi-Oblique Platform 3.2mm Tool Guide
• 00873263008096: Multi-Oblique Platform 3.2mm Tool Guide (60mm), 1X
• 00873263008621: Multi-Oblique Platform 2.5mm Tool Guide (60mm), 1X