SmartFrame OR NGS-SFOR-DG-07

GUDID 00850376007956

SmartFrame OR Drill Guide Kit, 3.4 & 4.5mm

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 Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00850376007956
• NIH Device Record Key: bd52de72-6171-4dbf-be8f-b932fb9730f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame OR
• Version Model Number: NGS-SFOR-DG-07
• Catalog Number: NGS-SFOR-DG-07
• Company DUNS: 119078557
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850376007956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233141

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: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [SmartFrame OR]

• 00850376007956: SmartFrame OR Drill Guide Kit, 3.4 & 4.5mm
• 00850376007949: SmartFrame OR ClearPointer Kit - StealthStation
• 00850376007932: SmartFrame OR Kit
• 00850047354044: SmartFrame OR Bone Screw Fiducial Kit
• 00850047354037: SmartFrame OR Depth Setter Kit
• 00850047354020: SmartFrame OR Scalp Mount Base
• 00850047354013: SmartFrame OR Skull Mount Base
• 00850047354006: SmartFrame OR Drill Guide, 5.4mm