SmartFrame CP-NGS-11-TE-CG45

GUDID 00850359007010

SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE

MRI INTERVENTIONS, INC.

Neurological stereotactic surgery system
Primary Device ID00850359007010
NIH Device Record Key7d8c80ac-7a42-4bba-8b76-f9167d42806b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartFrame
Version Model NumberCP-NGS-11-TE-CG45
Catalog NumberCP-NGS-11-TE-CG45
Company DUNS959181160
Company NameMRI INTERVENTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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
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
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

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
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
GS100850359007010 [Primary]

FDA Product Code

ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-12

On-Brand Devices [SmartFrame]

00850359007041SMARTFrame Scalp Mount Rescue Screw- Short
00850359007040SMARTFrame Scalp Mount Rescue Screw - Long
00850359007039SMARTFrame Skull Mount Rescue Screw
00850359007038SMARTFrame Wharen Centering Guide
00850359007033SmartFrame® Skull Mount Base
00850359007032SMARTFrame Scalp Mount Base
00850359007031SmartFrame® XG Exchangeable Device Guide, 4.5-mm
00850359007030SMARTFrame XG Exchangeable Device Guides
00850359007028SMARTFrame Guide Tubes .074” / 15 ga
00850359007027SMARTFrame Guide Tubes .068” / 16 ga
00850359007026SMARTFrame Guide Tubes .064” / CP Stylet
00850359007025SMARTFrame Guide Tubes .060” / 17 ga
00850359007024SMARTFrame Guide Tubes .052” / 18 ga
00850359007023SMARTFrame Guide Tubes
00850359007017SMARTFrame Thumb Wheel Extension Set
00850359007016SMARTFrame Hand Controller
00850359007015SMARTFrame Accessory Kit
00850359007013SMARTFrame MRI-Guided Trajectory Tower w/o Base
00850359007012SMARTFrame XG MRI-Guided Trajectory Frame
00850359007011SMARTFrame MRI-Guided Trajectory Frame
00850359007010SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE
00850359007009SMARTFrame XG 4.5 TwistPoint Kit w/ TE
00850359007008SMARTFrame XG 4.5 TwistPoint Kit w/ HC
00850359007007SMARTFrame XG TwistPoint Kit w/ HC - E
00850359007005SMARTFrame XG TwistPoint Kit w/ HC
00850359007004SMARTFrame Scalp Mount Kit w/ TE
00850359007003SMARTFrame Scalp Mount Kit w/ HC
00850359007002SMARTFrame Kit w/ TE
00850359007001SMARTFrame Kit w/ HC

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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