SMARTFrame Expanded Accessory Kit, 5 Fr NGS-EAK-01-11-5

GUDID 00850047354068

SMARTFrame Expanded Accessory Kit, 5 Fr

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

• Primary Device ID: 00850047354068
• NIH Device Record Key: 79a0c55e-c058-4ebe-a46c-93b5469e0042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTFrame Expanded Accessory Kit, 5 Fr
• Version Model Number: NGS-EAK-01-11-5
• Catalog Number: NGS-EAK-01-11-5
• Company DUNS: 119078557
• Company Name: Clearpoint Neuro, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047354068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200079

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: 2024-05-24
• Device Publish Date: 2024-05-16

Devices Manufactured by Clearpoint Neuro, Inc.

• 00850047354051 - ClearPoint Mobile Equipment Cart: 2024-05-24 ClearPoint Mobile Equipment Cart
• 00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr: 2024-05-24SMARTFrame Expanded Accessory Kit, 5 Fr
• 00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr: 2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr
• 00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr: 2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr
• 00850376007925 - Bone Anchor: 2024-05-24 Bone Anchor
• 00850047354006 - SmartFrame OR: 2024-03-19 SmartFrame OR Drill Guide, 5.4mm
• 00850047354013 - SmartFrame OR: 2024-03-19 SmartFrame OR Skull Mount Base
• 00850047354020 - SmartFrame OR: 2024-03-19 SmartFrame OR Scalp Mount Base
• 00850047354037 - SmartFrame OR: 2024-03-19 SmartFrame OR Depth Setter Kit