SmartFrame NGS-CG-01

GUDID 00850359007386

SMARTFrame Wharen Centering Guide

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00850359007386
NIH Device Record Keya0da2ca7-f202-4f88-bb65-0fed2e3196f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartFrame
Version Model NumberNGS-CG-01
Catalog NumberNGS-CG-01
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument
ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-22

On-Brand Devices [SmartFrame]

08503590070412SMARTFrame Scalp Mount Rescue Screw- Short
08503590070405SMARTFrame Scalp Mount Rescue Screw - Long
08503590070399SMARTFrame Skull Mount Rescue Screw
08503590070382SMARTFrame Wharen Centering Guide
08503590070337SmartFrame® Skull Mount Base
08503590070320SMARTFrame Scalp Mount Base
08503590070313SmartFrame® XG Exchangeable Device Guide, 4.5-mm
08503590070306SMARTFrame XG Exchangeable Device Guides
08503590070283SMARTFrame Guide Tubes .074” / 15 ga
08503590070276SMARTFrame Guide Tubes .068” / 16 ga
08503590070269SMARTFrame Guide Tubes .064” / CP Stylet
08503590070252SMARTFrame Guide Tubes .060” / 17 ga
08503590070245SMARTFrame Guide Tubes .052” / 18 ga
08503590070238SMARTFrame Guide Tubes
08503590070177SMARTFrame Thumb Wheel Extension Set
08503590070160SMARTFrame Hand Controller
08503590070153SMARTFrame Accessory Kit
08503590070139SMARTFrame MRI-Guided Trajectory Tower w/o Base
08503590070122SMARTFrame XG MRI-Guided Trajectory Frame
08503590070115SMARTFrame MRI-Guided Trajectory Frame
08503590070108SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE
08503590070092SMARTFrame XG 4.5 TwistPoint Kit w/ TE
08503590070085SMARTFrame XG 4.5 TwistPoint Kit w/ HC
08503590070078SMARTFrame XG TwistPoint Kit w/ HC - E
08503590070054SMARTFrame XG TwistPoint Kit w/ HC
08503590070047SMARTFrame Scalp Mount Kit w/ TE
08503590070030SMARTFrame Scalp Mount Kit w/ HC
08503590070023SMARTFrame Kit w/ TE
08503590070016SMARTFrame Kit w/ HC
00850359007416SMARTFrame Scalp Mount Rescue Screw- Short
00850359007409SMARTFrame Scalp Mount Rescue Screw - Long
00850359007393SMARTFrame Skull Mount Rescue Screw
00850359007386SMARTFrame Wharen Centering Guide
00850359007331SmartFrame® Skull Mount Base
00850359007324SMARTFrame Scalp Mount Base
00850359007317SmartFrame® XG Exchangeable Device Guide, 4.5-mm
00850359007300SMARTFrame XG Exchangeable Device Guides
00850359007287SMARTFrame Guide Tubes .074” / 15 ga
00850359007270SMARTFrame Guide Tubes .068” / 16 ga
00850359007263SMARTFrame Guide Tubes .064” / CP Stylet
00850359007256SMARTFrame Guide Tubes .060” / 17 ga
00850359007249SMARTFrame Guide Tubes .052” / 18 ga
00850359007232SMARTFrame Guide Tubes
00850359007171SMARTFrame Thumb Wheel Extension Set
00850359007164SMARTFrame Hand Controller
00850359007157SMARTFrame Accessory Kit
00850359007133SMARTFrame MRI-Guided Trajectory Tower w/o Base
00850359007126SMARTFrame XG MRI-Guided Trajectory Frame
00850359007119SMARTFrame MRI-Guided Trajectory Frame
00850359007102SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE

Trademark Results [SmartFrame]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTFRAME
SMARTFRAME
97128687 not registered Live/Pending
Andrew Zucaro
2021-11-17
SMARTFRAME
SMARTFRAME
87211183 5231695 Live/Registered
Craco Manufacturing, Inc.
2016-10-21
SMARTFRAME
SMARTFRAME
85462619 4266797 Dead/Cancelled
ForceProtector Gear, LLC
2011-11-02
SMARTFRAME
SMARTFRAME
85443529 4189474 Live/Registered
Indiana Mills & Manufacturing, Inc.
2011-10-10
SMARTFRAME
SMARTFRAME
85305736 not registered Dead/Abandoned
Rose Displays Ltd.
2011-04-27
SMARTFRAME
SMARTFRAME
77678902 3679602 Dead/Cancelled
Craco Manufacturing Inc.
2009-02-26
SMARTFRAME
SMARTFRAME
77618553 3829065 Live/Registered
MRI INTERVENTIONS, INC.
2008-11-20
SMARTFRAME
SMARTFRAME
77547326 not registered Dead/Abandoned
SmartSpace Development, LLC
2008-08-14
SMARTFRAME
SMARTFRAME
77093097 3886564 Live/Registered
Sit, Hon P.
2007-01-29
SMARTFRAME
SMARTFRAME
76402599 2884771 Live/Registered
ODL, Incorporated
2002-04-29
SMARTFRAME
SMARTFRAME
76041320 2539444 Dead/Cancelled
eFrame Technology Solutions, LLC
2000-05-05
SMARTFRAME
SMARTFRAME
74467260 1886008 Dead/Cancelled
CANADIAN CENTRE FOR HIGH PERFORMANCE INC.
1993-12-08

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