ClearPoint Array CPA-SFW-11-12

GUDID 00850376007871

ClearPoint Array Software Version 1.2

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system
Primary Device ID00850376007871
NIH Device Record Key473d04b4-f455-47ef-8a00-3f9ad939bb52
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearPoint Array
Version Model NumberCPA-SFW-11-12
Catalog NumberCPA-SFW-11-12
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100850376007871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-06
Device Publish Date2023-10-27

On-Brand Devices [ClearPoint Array]

00850359007744ClearPoint Lite Software
00850376007659ClearPoint Array Software Version 1.1
00850376007895ClearPoint Array v1.2.x Neuro Workstation
00850376007871ClearPoint Array Software Version 1.2

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