OsteoMed™ Manual Driver Handle 66-WP-DH

GUDID 00873263003237

OsteoMed Manual Driver Handle

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263003237
• NIH Device Record Key: 55885852-5b45-42e1-8c44-d39c8f3220bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoMed™ Manual Driver Handle
• Version Model Number: 66-WP-DH-00323
• Catalog Number: 66-WP-DH
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003237 [Primary]

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

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263003237]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-07
• Device Publish Date: 2016-09-17

Devices Manufactured by FHC, INC.

• 10873263009427 - microTargeting™ Electrode: 2025-05-29 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263009413 - microTargeting™ Electrode: 2025-05-29 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263008690 - Nexframe: 2025-05-08 Bilateral Nexframe System for Medtronic StealthStation Navigation Systems
• 00873263008706 - NEXDRIVE™ w/DIG: 2025-05-08 MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
• 00873263008713 - NEXDRIVE™: 2025-05-08 MI-2000 NEXDRIVE™ Micropositioning Drive
• 00873263008720 - Nexprobe®: 2025-05-08 NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation System
• 00873263008904 - microTargeting™ Single Procedure Kit: 2025-05-08 microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tu
• 00873263008928 - microTargeting™ Insertion Tube Set: 2025-05-08 microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One E