SmartTip NGS-DB-45-S

GUDID 00850359007959

SmartTip MR Short Drill Bit Kit

CLEARPOINT NEURO, INC.

Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use
Primary Device ID00850359007959
NIH Device Record Keya41f4ae6-6789-40f9-84a5-d12de8308ad3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartTip
Version Model NumberNGS-DB-45-S
Catalog NumberNGS-DB-45-S
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch
Outer Diameter4.5 Millimeter
Length6.75 Inch

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007959 [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 Date2021-04-15
Device Publish Date2021-04-07

On-Brand Devices [SmartTip]

08503590070368SmartTip MRII Drill Kit, 4.5 mm
08503590070351SmartTip MRII Drill Kit, 3.2-mm
00850359007362SmartTip MRII Drill Kit, 4.5 mm
00850359007355SmartTip MRII Drill Kit, 3.2-mm
00850359007959SmartTip MR Short Drill Bit Kit

Trademark Results [SmartTip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTTIP
SMARTTIP
97912498 not registered Live/Pending
ComeBack Mobility, Inc.
2023-04-28
SMARTTIP
SMARTTIP
90453287 not registered Live/Pending
Graco Minnesota Inc.
2021-01-07
SMARTTIP
SMARTTIP
90005406 not registered Live/Pending
Olympus Corporation
2020-06-17
SMARTTIP
SMARTTIP
86470543 not registered Dead/Abandoned
Banos, Juan
2014-12-03
SMARTTIP
SMARTTIP
85932647 4512580 Live/Registered
MRI Interventions, Inc.
2013-05-15
SMARTTIP
SMARTTIP
78364165 2956150 Dead/Cancelled
Comarco Wireless Technologies, Inc.
2004-02-06
SMARTTIP
SMARTTIP
77128043 3799914 Live/Registered
Olympus Corporation
2007-03-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.