Neuro Omega MER Headstage 750-000023-00

GUDID 07290114062367

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID07290114062367
NIH Device Record Keybc207897-3b65-4fe1-9dcd-9e0d4e1b8670
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega MER Headstage
Version Model NumberNeuro Omega MER Headstage
Catalog Number750-000023-00
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
GS107290114062367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


[07290114062367]

Hydrogen Peroxide


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.

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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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