NeuroNav main unit 700-006002-00

GUDID 07290114061513

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290114061513
NIH Device Record Key19debeb5-a86f-44a1-bc8c-49263ba516b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav main unit
Version Model NumberNeuroNav main unit
Catalog Number700-006002-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS107290114061513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

07290114064057 - Remote Control2024-01-12
07290114064064 - Remote Control2024-01-12
07290114064071 - HaGuide Software2024-01-09
07290114064149 - Bengun W/O Screws2024-01-09
07290114064156 - Bengun Adapter2024-01-09
07290014954083 - NeuroSmart Main Unit2024-01-08
07290016450019 - NeuroSmart MER Headstage2024-01-08
07290114060790 - NeuroSmart NeuroForits Drive Headstage2024-01-08

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