SmartFrarme CP-NGS-11-TE-TP32

GUDID 00850359007006

SMARTFrame XG TwistPoint Kit w/ TE

MRI INTERVENTIONS, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00850359007006
• NIH Device Record Key: 7c4f11b2-3be7-4941-930e-628d8e6efcc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrarme
• Version Model Number: CP-NGS-11-TE-TP32
• Catalog Number: CP-NGS-11-TE-TP32
• Company DUNS: 959181160
• Company Name: MRI INTERVENTIONS, 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: 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	00850359007006 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-12

Devices Manufactured by MRI INTERVENTIONS, INC.

• 00850359007042 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 15mm tip
• 00850359007043 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 15mm tip
• 00850359007044 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 15mm tip
• 00850359007045 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip
• 00850359007046 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 12mm tip
• 00850359007047 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 10mm tip
• 00850359007048 - Smartflow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip
• 00850359007049 - SmartFlow: 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short)