ClearPoint 7 Fr Accessory Kit NGS-AK-01-11-7

GUDID 00850359007829

Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel away sheath that accepts 7 Fr devices

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID00850359007829
NIH Device Record Key368b2014-3bc1-49ca-8b6e-cbbe9e80c163
Commercial Distribution Discontinuation2035-04-30
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearPoint 7 Fr Accessory Kit
Version Model NumberNGS-AK-01-11-7
Catalog NumberNGS-AK-01-11-7
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 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
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
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

Device Dimensions

Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
Introducer Sheath Compatibilit7 French
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Introducer Sheath Compatibilit7 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850359007829 [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 Date2021-02-01
Device Publish Date2021-01-22

On-Brand Devices [ClearPoint 7 Fr Accessory Kit]

08503590070825Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel away sheath that ac
00850359007829Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel away sheath that ac

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