HaGuide Software 407-000024-00

GUDID 07290114064071

ALPHA OMEGA ENGINEERING CO. LTD.

Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system Brain-responsive electrical stimulation system
Primary Device ID07290114064071
NIH Device Record Key759a4d96-dc48-46eb-a03f-a121cdc087e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHaGuide Software
Version Model NumberHaGuide Software
Catalog Number407-000024-00
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 Numberfalse
Manufacturing Datefalse
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
GS107290114064071 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-01-09
Device Publish Date2022-11-08

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

07290114064057 - Remote Control2024-01-12
07290114064064 - Remote Control2024-01-12
07290114064071 - HaGuide Software2024-01-09
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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