SmartTwist NGS-HD-01

GUDID 00850359007348

SmartTwist MRII Hand Drill

CLEARPOINT NEURO, INC.

Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use Manual cranial rotary handpiece, single-use
Primary Device ID00850359007348
NIH Device Record Key84bc58ca-cc45-44c5-978b-9bf16aed2ab5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartTwist
Version Model NumberNGS-HD-01
Catalog NumberNGS-HD-01
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 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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007348 [Primary]

FDA Product Code

HBGDrills, Burrs, Trephines & Accessories (Manual)
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 [SmartTwist]

08503590070344SmartTwist MRII Hand Drill
00850359007348SmartTwist MRII Hand Drill

Trademark Results [SmartTwist]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTTWIST
SMARTTWIST
85932641 4512579 Live/Registered
MRI Interventions, Inc.
2013-05-15

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