SmartFrame Array Thumbwheel Extension

GUDID 00850359007935

Thumb wheel extension used with SmartFrame Array navigation frame

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system
Primary Device ID00850359007935
NIH Device Record Key32397f13-fc42-4187-8a60-21ce33514eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartFrame Array Thumbwheel Extension
Version Model NumberNGS-SFA-TE-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 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
GS100850359007935 [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

Devices Manufactured by CLEARPOINT NEURO, INC.

00850047354051 - ClearPoint Mobile Equipment Cart2024-05-24 ClearPoint Mobile Equipment Cart
00850047354068 - SMARTFrame Expanded Accessory Kit, 5 Fr2024-05-24 SMARTFrame Expanded Accessory Kit, 5 Fr
00850047354075 - SMARTFrame Expanded Accessory Kit, 7 Fr2024-05-24 SMARTFrame Expanded Accessory Kit, 7 Fr
00850376007925 - Bone Anchor2024-05-24 Bone Anchor
00850047354006 - SmartFrame OR2024-03-19 SmartFrame OR Drill Guide, 5.4mm
00850047354013 - SmartFrame OR2024-03-19 SmartFrame OR Skull Mount Base
00850047354020 - SmartFrame OR2024-03-19 SmartFrame OR Scalp Mount Base
00850047354037 - SmartFrame OR2024-03-19 SmartFrame OR Depth Setter Kit

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