Smartflow NGS-NC-07

GUDID 08503590070481

Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip

CLEARPOINT NEURO, INC.

Vascular microcatheter

• Primary Device ID: 08503590070481
• NIH Device Record Key: 36a2d652-d5f2-4238-a82c-8f83ffbfaa0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smartflow
• Version Model Number: NGS-NC-07
• Catalog Number: NGS-NC-07
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102101

FDA Product Code

• HCD: Cannula, Ventricular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-12
• Device Publish Date: 2016-08-12

On-Brand Devices [Smartflow]

• 08503590070498: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short)
• 08503590070481: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip
• 08503590070474: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 10mm tip
• 08503590070467: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 12mm tip
• 08503590070450: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip
• 08503590070443: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 15mm tip
• 08503590070436: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 15mm tip
• 08503590070429: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 15mm tip
• 00850359007492: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short)
• 00850359007485: Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip
• 00850359007478: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 10mm tip
• 00850359007461: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 12mm tip
• 00850359007454: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip
• 00850359007447: Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 15mm tip
• 00850359007430: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 15mm tip
• 00850359007423: Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 15mm tip