NeuroSmart Main Unit

GUDID 07290014954083

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID07290014954083
NIH Device Record Keyb08ab474-052f-4aaf-a08d-ec4576bfa5db
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart Main Unit
Version Model NumberNeuroSmart Main Unit
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS107290014954083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


[07290014954083]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-30

On-Brand Devices [NeuroSmart Main Unit]

07290114061544NeuroSmart Main Unit
07290014954083NeuroSmart Main Unit

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