NaviNetics Skull Anchor Extended Rescue Screw Kit NN1600

GUDID 10850023620214

Navinetics, Inc.

Neurological stereotactic surgery system
Primary Device ID10850023620214
NIH Device Record Keyf5f72815-d301-4a44-88ed-fb12b8bd91a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviNetics Skull Anchor Extended Rescue Screw Kit
Version Model NumberNN1600
Catalog NumberNN1600
Company DUNS838320260
Company NameNavinetics, Inc.
Device Count20
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 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
GS110850023620214 [Primary]
GS110850023620238 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


[10850023620214]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

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
10850023620214 - NaviNetics Skull Anchor Extended Rescue Screw Kit2023-08-01

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