microTargeting™ NexFrame™ Drive Adapter 66-DM-02

GUDID 00873263001837

microTargeting(TM) Drive Mount Adapter for use with NexFrame

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263001837
• NIH Device Record Key: 5b53b989-7347-4bd7-9e7d-e096308eb594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ NexFrame™ Drive Adapter
• Version Model Number: 66-DM-02-00429
• Catalog Number: 66-DM-02
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001837 [Direct Marking]
GS1	00873263004296 [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

[00873263001837]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

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