NEXDRIVE™ w/DIG MI-1000

GUDID 00873263007716

MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00873263007716
• NIH Device Record Key: 659d2306-e76c-4b9d-9c9f-f863fb573c5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXDRIVE™ w/DIG
• Version Model Number: MI-1000-00771
• Catalog Number: MI-1000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022100

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263007716]

Ethylene Oxide

[00873263007716]

Ethylene Oxide

[00873263007716]

Ethylene Oxide

[00873263007716]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

Devices Manufactured by FHC, INC.

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• 00873263005453 - microTargeting™ Multi-Oblique Accessory: 2024-03-14 Multi-Oblique Sterilization and Storage Kit
• 00873263007044 - microTargeting™ Electrode Sterilization Tray: 2024-03-14 microTargeting Electrode Sterilization Tray
• 00873263002216 - STar™ Drive Frame Adapter Kit: 2024-03-12 STar(TM) Drive Platform Adaptor, Integrated Ring Version
• 00873263002353 - STar™ Drive Frame Adapter: 2024-03-12 STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames
• 00873263002384 - STar™ Drive Positioner: 2024-03-12 Offset Positioner, Short Bushing for STar(TM) Drive
• 00873263002452 - STar™ Drive Positioner: 2024-03-12 Center Positioner, Short Bushing for STar Drive