ClearPoint 5 Fr Accessory Kit NGS-AK-01-11-5

GUDID 00850359007812

An MRI Safe accessory kit with a 5 Fr stylet, lancet, and a peel away sheath that accepts ~5 Fr devices

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00850359007812
• NIH Device Record Key: 898e460f-1137-4edf-8fb4-24111b943781
• Commercial Distribution Discontinuation: 2035-04-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint 5 Fr Accessory Kit
• Version Model Number: NGS-AK-01-11-5
• Catalog Number: NGS-AK-01-11-5
• Company DUNS: 959181160
• 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: 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: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@clearpointneuro.com
• Phone: 949-900-6833
• Email: info@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
• 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
• 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
• 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

• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French
• Introducer Sheath Compatibilit: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850359007812 [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: 2021-02-01
• Device Publish Date: 2021-01-22

On-Brand Devices [ClearPoint 5 Fr Accessory Kit]

• 08503590070818: An MRI Safe accessory kit with a 5 Fr stylet, lancet, and a peel away sheath that accepts ~5 Fr
• 00850359007812: An MRI Safe accessory kit with a 5 Fr stylet, lancet, and a peel away sheath that accepts ~5 Fr