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.

• 10873263009267 - microTargeting™ Insertion Tube: 2024-10-08 microTargeting™ Insertion Tube with Stylet, 74mm
• 10873263009236 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 10873263009243 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263009253 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263009222 - STarFix™ Designer: 2024-07-22 STarFix™ Designer DBS
• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version
• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only
• 00873263002193 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame