SmartFrame XG TwistPoint Kit w/TE-7 CP-NGS-11-TP45-XG-7

GUDID 08503590070894

A procedure kit that packages several individually boxed and packaged ClearPoint kits together. Contains the SmartFrame XG-7.

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system

• Primary Device ID: 08503590070894
• NIH Device Record Key: ba6d3b43-bbae-4a72-8b40-d1fd3e3177b5
• Commercial Distribution Discontinuation: 2035-04-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame XG TwistPoint Kit w/TE-7
• Version Model Number: CP-NGS-11-TP45-XG-7
• Catalog Number: CP-NGS-11-TP45-XG-7
• Company DUNS: 959181160
• Company Name: CLEARPOINT NEURO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com
• Phone: 9499006833
• Email: customerservice@clearpointneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070894 [Primary]

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: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [SmartFrame XG TwistPoint Kit w/TE-7 ]

• 08503590070894: A procedure kit that packages several individually boxed and packaged ClearPoint kits together.
• 00850359007898: A procedure kit that packages several individually boxed and packaged ClearPoint kits together.