SmartFlow

Basic Information

• Brand Name: SmartFlow
• Primary DI: 00850359007478
• Version / Model: NGS-NC-06
• Catalog Number: NGS-NC-06
• Company Name: Clearpoint Neuro, Inc.
• Labeler DUNS: 119078557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-22
• Public Version: 6
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: e02f0e90-b975-4952-ad10-f8152b14ee00

Device Description

Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 13mm tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCD	Cannula, Ventricular	Neurology	882.4060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62753	Intracerebral cannula, nonimplantable, single-use	A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850359007478	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102101	000

Device Sizes

Type	Value	Unit	Text
Length	10	Feet
Lumen/Inner Diameter	.008	Inch
Device Size Text, specify			Tip length 10mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 90 Degrees Fahrenheit