SmartFrame XG-7 Fr NGS-SF-02-11-7

GUDID 08503590070849

MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system
Primary Device ID08503590070849
NIH Device Record Keya0710d29-221f-4632-9ea2-77828f740f96
Commercial Distribution Discontinuation2035-04-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartFrame XG-7 Fr
Version Model NumberNGS-SF-02-11-7
Catalog NumberNGS-SF-02-11-7
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108503590070849 [Primary]

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 Date2020-10-14
Device Publish Date2020-10-06

On-Brand Devices [SmartFrame XG-7 Fr]

08503590070849MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD
00850359007843MRI Guided trajectory frame that is compatible with devices with ~ 7 Fr OD

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.