V-TAG NGS-VT-01

GUDID 08503590070733

V-TAG TRAJECTORY ARRAY GUIDE

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system

• Primary Device ID: 08503590070733
• NIH Device Record Key: d195df6b-f771-4e7f-a398-0c411bcd0b3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-TAG
• Version Model Number: NGS-VT-01
• Catalog Number: NGS-VT-01
• Company DUNS: 959181160
• Company Name: CLEARPOINT NEURO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 949-900-6833
• Email: info@mriinterventions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180854

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-12
• Device Publish Date: 2019-03-22

On-Brand Devices [V-TAG]

• 08503590070733: V-TAG TRAJECTORY ARRAY GUIDE
• 00850359007737: V-TAG TRAJECTORY ARRAY GUIDE