NaviNetics Reusable Stereotactic System

GUDID 10850023620078

Navinetics, Inc.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system
Primary Device ID10850023620078
NIH Device Record Key8d17df61-0e6b-482d-a02d-a7107d57ffbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviNetics Reusable Stereotactic System
Version Model NumberNN1000
Company DUNS838320260
Company NameNavinetics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110850023620078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10850023620078]

Moist Heat or Steam Sterilization


[10850023620078]

Moist Heat or Steam Sterilization


[10850023620078]

Moist Heat or Steam Sterilization


[10850023620078]

Moist Heat or Steam Sterilization


[10850023620078]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-16
Device Publish Date2022-11-08

Devices Manufactured by Navinetics, Inc.

10850023620245 - NaviNetics Driver Handle 2023-11-20
10850023620269 - NaviNetics Standard Skull Anchor Screw2023-11-20
10850023620276 - NaviNetics Skull Anchor Key and Drill 2023-11-20
10850023620177 - NaviNetics Cannula and Stylet Kit (To Target) 2023-08-01
10850023620184 - NaviNetics Microdrive Adapter A2023-08-01
10850023620191 - NaviNetics Microdrive Adapter F2023-08-01
10850023620207 - NaviNetics Skull Anchor Extended Screw Kit2023-08-01
10850023620214 - NaviNetics Skull Anchor Extended Rescue Screw Kit2023-08-01

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