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

• 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