SmartFrame XG-5 Fr NGS-SF-02-11-5

GUDID 08503590070832

MRI Guided trajectory frame that can be used with devices ~ 5 Fr in OD

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 08503590070832
• NIH Device Record Key: 9f43b805-8af8-479d-a87c-23fb5be57599
• Commercial Distribution Discontinuation: 2035-04-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame XG-5 Fr
• Version Model Number: NGS-SF-02-11-5
• Catalog Number: NGS-SF-02-11-5
• Company DUNS: 959181160
• Company Name: CLEARPOINT NEURO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com
• Phone: 9499006833
• Email: info@clearpointneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070832 [Primary]

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [SmartFrame XG-5 Fr]

• 08503590070832: MRI Guided trajectory frame that can be used with devices ~ 5 Fr in OD
• 00850359007836: MRI Guided trajectory frame that can be used with devices ~ 5 Fr in OD