SMARTFrame Expanded Accessory Kit, 7 Fr NGS-EAK-01-11-7

GUDID 00850047354075

SMARTFrame Expanded Accessory Kit, 7 Fr

Clearpoint Neuro, Inc.

Neurological stereotactic surgery system

• Primary Device ID: 00850047354075
• NIH Device Record Key: 5f2b7100-a96f-4da4-b706-e2a9d4c65dd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTFrame Expanded Accessory Kit, 7 Fr
• Version Model Number: NGS-EAK-01-11-7
• Catalog Number: NGS-EAK-01-11-7
• 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	00850047354075 [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.

• 00850047354082 - ClearPoint: 2025-05-29 Depth Stops (6pk)
• 00850047354099 - ClearPoint: 2025-02-13 ClearPoint - Software Version 3.0
• 00850047354136 - ClearPoint: 2025-02-13 ClearPoint Neuro Workstation - Win 11
• 00850047354105 - SmartFlow: 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 4 ft x 18mm tip
• 00850047354112 - SmartFlow: 2024-12-03 SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip
• 00850047354051 - ClearPoint Mobile Equipment Cart: 2024-05-24 ClearPoint Mobile Equipment Cart
• 00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr: 2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr
• 00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr: 2024-05-24SMARTFrame Expanded Accessory Kit, 7 Fr
• 00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr: 2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr