SmartTwist NGS-HD-01

GUDID 08503590070344

SmartTwist MRII Hand Drill

CLEARPOINT NEURO, INC.

Manual cranial rotary handpiece, single-use

• Primary Device ID: 08503590070344
• NIH Device Record Key: e2fbbfe7-95a0-4cc3-a003-5fdb5f910534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartTwist
• Version Model Number: NGS-HD-01
• Catalog Number: NGS-HD-01
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-900-6833
• Email: info@mriinterventions.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070344 [Primary]

FDA Product Code

• ORR: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-12
• Device Publish Date: 2016-08-12

On-Brand Devices [SmartTwist]

• 08503590070344: SmartTwist MRII Hand Drill
• 00850359007348: SmartTwist MRII Hand Drill