microTargeting™ Drive DBS Adapter 66-CN-DB

GUDID 00873263004531

DBS Lead Adapter for microTargeting(TM) Drive

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 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 Neurosurgical micro targeting drive

• Primary Device ID: 00873263004531
• NIH Device Record Key: df9a010b-e862-4273-827d-5e325597049a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Drive DBS Adapter
• Version Model Number: 66-CN-DB-00453
• Catalog Number: 66-CN-DB
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• 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

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
• 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
• 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
• 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	00873263004531 [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

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263004531]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-03-12
• Device Publish Date: 2016-09-21

On-Brand Devices [microTargeting™ Drive DBS Adapter]

• 00873263001790: DBS Lead Adapter for microTargeting(TM) Drive
• 00873263004531: DBS Lead Adapter for microTargeting(TM) Drive