ClearPoint CP-INHFF-422-01

GUDID 00850376007567

ClearPoint Inflexion Head Fixation Frame/Table Mount for Philips Ingenia scanner tables

CLEARPOINT NEURO, INC.

Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame Stereotactic radiosurgical invasive head frame
Primary Device ID00850376007567
NIH Device Record Keye050da05-9c87-43fd-aa15-ed7ede9be61f
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearPoint
Version Model NumberCP-INHFF-422-01
Catalog NumberCP-INHFF-422-01
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 Usefalse
Lot Batchtrue
Serial Numbertrue
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@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
Emailinfo@clearpointneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]
GS100850376007567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBLHolder, Head, Neurosurgical (Skull Clamp)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

On-Brand Devices [ClearPoint]

08503760070464ClearPoint IMRIS Aera-Skyra Multi-Positional Head Fixation Frame
08503760070457ClearPoint IMRIS Aera-Skyra Head Fixation Frame
08503760070440ClearPoint IMRIS ORT 400 Table Extension
08503760070433ClearPoint IMRIS Table Stabilizer - Aera/Skyra
08503760070426ClearPoint ® IMRIS Universal Multi-Positional Head Fixation Frame
08503760070419ClearPoint ® IMRIS Universal Head Fixation Frame
08503760070402GE Housing Cover
08503760070396ClearPoint Multi-Positional Lower HFF Screws for Philips
08503760070389ClearPoint Multi-Positional Lower HFF Screws for GE, Siemens and IMRIS
08503760070372ClearPoint Multi-Positional Upper Fixation Frame Screws
08503760070365ClearPoint GE Compatible Fixation Frame Screws
08503760070358ClearPoint Fixation Frame Screws, Philips
08503760070341ClearPoint Fixation Frame Screws
08503760070334ClearPoint Multi-Positional HFF/Table Mounts for Philips Ingenia
08503760070327ClearPoint Multi-Positional HFF/Table Mounts for Philips Achieva
08503760070310ClearPoint Multi-Positional HFF/Table Mounts for GE 750W
08503760070303ClearPoint Multi-Positional HFF/Table Mounts for GE HDw (450w) Table
08503760070297ClearPoint Multi-Positional HFF/Table Mounts for GE HDx Table
08503760070280ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 200 Table
08503760070273ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 100 Table
08503760070266ClearPoint Multi-Positional HFF/Table Mounts for IMRIS with Base
08503760070259ClearPoint Multi-Positional HF/Table Mounts for Siemens Aera/Skyra
08503760070242ClearPoint Multi-Positional HFF/Table Mounts for Siemens Avanto/Espree/Symphony/Sonata
08503760070235ClearPoint Adjustable Table Mount, Philips Ingenia - DORO
08503760070228ClearPoint Adjustable Table Mount, Philips Achieva -DORO
08503760070211ClearPoint Adjustable Table Mount, GE 750w-Integra
08503760070204ClearPoint Adjustable Table Mount, GE 450w (HDw)-Integra
08503760070198ClearPoint Adjustable Table Mount, GE HDx-Integra
08503760070181ClearPoint® Adjustable Table Mount, IMRIS - Integra
08503760070174ClearPoint® Adjustable Table Mount, IMRIS - DORO
08503760070167ClearPoint® Adjustable Table Mount, SMS Aera/Skyra - DORO
08503760070150ClearPoint® Adjustable Table Mount, SMS Avanto - DORO
08503760070143ClearPoint Philips Ingenia Table Head Fixation Frame
08503760070136ClearPoint Philips Achieva Table Head Fixation Frame
08503760070129ClearPoint® GE 750w Table Head Fixation Frame
08503760070112ClearPoint GE HDw (450w) Table Head Fixation Frame
08503760070105ClearPoint GE HDx Table Head Fixation Frame
08503760070099ClearPoint IMRIS Stabilizer Ramp
08503760070082ClearPoint IMRIS Table Stabilizer
08503760070075ClearPoint IMRIS ORT 200 Table Extension
08503760070068ClearPoint® IMRIS ORT 200 Head Fixation Frame
08503760070051ClearPoint® IMRIS ORT 100 Head Fixation Frame
08503760070044ClearPoint IMRIS T –Series Table Head Fixation Frame/Base
08503760070037ClearPoint® Siemens Aera/Skyra Table Head Fixation Frame
08503760070020ClearPoint® Siemens Avanto/Espree/ Symphony/Sonata Table HFF
08503760070013ClearPoint SMS Avanto/Espree/ Symphony/Sonata Table HFF/Base
08503590070665SmartFrame XG Burr Hole Kit with Skull Mount
08503590070658SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits - No Hand Drill
08503590070641SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits and Hand Drill
08503590070634SmartFrame Burr Hole Kit with Scalp Mount

Trademark Results [ClearPoint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARPOINT
CLEARPOINT
88169831 not registered Live/Pending
The Matworks Company, LLC
2018-10-25
CLEARPOINT
CLEARPOINT
86906314 5138865 Live/Registered
MONEY MANAGEMENT INTERNATIONAL, INC.
2016-02-12
CLEARPOINT
CLEARPOINT
86906288 5138864 Live/Registered
MONEY MANAGEMENT INTERNATIONAL, INC.
2016-02-12
CLEARPOINT
CLEARPOINT
86244623 not registered Dead/Abandoned
AFFINITY MANAGEMENT LTD.
2014-04-07
CLEARPOINT
CLEARPOINT
86048269 4629693 Live/Registered
Taft & Partners, LLC
2013-08-26
CLEARPOINT
CLEARPOINT
85790340 4437532 Live/Registered
Gunilla of sweden, Inc
2012-11-29
CLEARPOINT
CLEARPOINT
85526916 4597587 Live/Registered
Apogee Enterprises, Inc.
2012-01-27
CLEARPOINT
CLEARPOINT
85146100 4120374 Dead/Cancelled
ClearPoint Learning Systems, Inc.
2010-10-06
CLEARPOINT
CLEARPOINT
85146096 4095332 Dead/Cancelled
ClearPoint Learning Systems, Inc.
2010-10-06
CLEARPOINT
CLEARPOINT
78923975 3451368 Dead/Cancelled
ZENO CORPORATION
2006-07-06
CLEARPOINT
CLEARPOINT
78487006 not registered Dead/Abandoned
Tyrell, Incorporated
2004-09-21
CLEARPOINT
CLEARPOINT
78486998 not registered Dead/Abandoned
ZENO CORPORATION
2004-09-21

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