MRII NGS-EC-16X24-06

GUDID 00850359007294

Flexible Self Adhesive Equipment Cover,16 x 24, 6 mil

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
Primary Device ID00850359007294
NIH Device Record Key3f42dbc7-c79f-4f40-8b11-525a363ec4ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRII
Version Model NumberNGS-EC-16X24-06
Catalog NumberNGS-EC-16X24-06
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007294 [Primary]

FDA Product Code

ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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 [MRII]

08503590070290Flexible Self Adhesive Equipment Cover,16 x 24, 6 mil
00850359007294Flexible Self Adhesive Equipment Cover,16 x 24, 6 mil

Trademark Results [MRII]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MRII
MRII
87515998 not registered Dead/Abandoned
Millennium Resilient International Inc.
2017-07-05
MRII
MRII
74306581 1851894 Dead/Cancelled
Micro-Computer Imports, Inc.
1992-08-24

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