SmartFrame Array

GUDID 00850359007928

Guide tube kit for SmartFrame Array-Contains guide tubes and device locks

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system
Primary Device ID00850359007928
NIH Device Record Keyd29417d2-cfb9-4164-8f8f-d84be1125b83
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartFrame Array
Version Model NumberNGS-SFA-GT-01
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailinfo@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com
Phone9499006833
Emailquality@clearpointneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

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 [SmartFrame Array]

00850359007928Guide tube kit for SmartFrame Array-Contains guide tubes and device locks
00850376007598Array Kit with navigation frame, used mainly for burr hole procedures
00850376007710SmartFrame® Array Offset & Center Guides, 5.4mm

Trademark Results [SmartFrame Array]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMARTFRAME ARRAY
SMARTFRAME ARRAY
88921112 not registered Live/Pending
ClearPoint Neuro, Inc.
2020-05-18

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