NeuroPort Inserter Assembly 4523

GUDID 00814901020049

Inserter Pneumatic Control Box

BLACKROCK MICROSYSTEMS, LLC

Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00814901020049
• NIH Device Record Key: a3bcd2e1-4a19-47ed-821f-999fecf76cb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPort Inserter Assembly
• Version Model Number: 4523
• Catalog Number: 4523
• Company DUNS: 827132015
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• 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: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901020049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042384

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [NeuroPort Inserter Assembly]

• 00814901020087: Head Holder Adapter
• 00814901020070: Inserter Wand Holder
• 00814901020063: Inserter Wand and Trigger Assembly 1.5mm
• 00814901020056: Inserter Wand and Trigger Assembly 1.0mm
• 00814901020049: Inserter Pneumatic Control Box