NeuroPort Inserter Assembly 4484

GUDID 00814901020087

Head Holder Adapter

BLACKROCK MICROSYSTEMS, LLC

Neurological stereotactic surgery system

• Primary Device ID: 00814901020087
• NIH Device Record Key: cf4ac80b-6636-4d7d-95f3-40a020e91332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPort Inserter Assembly
• Version Model Number: 4484
• Catalog Number: 4484
• 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	00814901020087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070272

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[00814901020087]

Moist Heat or Steam Sterilization

[00814901020087]

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: 2017-04-05

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