ClearPoint CP-SFW-11-201

GUDID 08503590070757

ClearPoint Software Ver. 2.0.1

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system

Primary Device ID	08503590070757
NIH Device Record Key	c4d9001d-ade8-4c26-a96b-cf5d46f42079
Commercial Distribution Status	In Commercial Distribution
Brand Name	ClearPoint
Version Model Number	CP-SFW-11-201
Catalog Number	CP-SFW-11-201
Company DUNS	959181160
Company Name	CLEARPOINT NEURO, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	949-900-6833
Email	info@mriinterventions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181195

FDA Product Code

ORR	Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-03-12
Device Publish Date	2018-12-12

On-Brand Devices [ClearPoint]

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

Trademark Results [ClearPoint]

Mark Image Registration \| Serial	Company Trademark Application Date
CLEARPOINT 98307609 not registered Live/Pending	CLEARPOINT NEURO, INC. 2023-12-11
CLEARPOINT 88169831 not registered Live/Pending	The Matworks Company, LLC 2018-10-25
CLEARPOINT 86906314 5138865 Live/Registered	MONEY MANAGEMENT INTERNATIONAL, INC. 2016-02-12
CLEARPOINT 86906288 5138864 Live/Registered	MONEY MANAGEMENT INTERNATIONAL, INC. 2016-02-12
CLEARPOINT 86244623 not registered Dead/Abandoned	AFFINITY MANAGEMENT LTD. 2014-04-07
CLEARPOINT 86048269 4629693 Live/Registered	Taft & Partners, LLC 2013-08-26
CLEARPOINT 85790340 4437532 Live/Registered	Gunilla of sweden, Inc 2012-11-29
CLEARPOINT 85526916 4597587 Live/Registered	Apogee Enterprises, Inc. 2012-01-27
CLEARPOINT 85146100 4120374 Dead/Cancelled	ClearPoint Learning Systems, Inc. 2010-10-06
CLEARPOINT 85146096 4095332 Dead/Cancelled	ClearPoint Learning Systems, Inc. 2010-10-06
CLEARPOINT 78923975 3451368 Dead/Cancelled	ZENO CORPORATION 2006-07-06
CLEARPOINT 78487006 not registered Dead/Abandoned	Tyrell, Incorporated 2004-09-21