Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots NOW-NFF000-00

GUDID 27290114063177

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114063177
NIH Device Record Key534fed10-afe7-47dd-9315-ff95495d2341
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots
Version Model NumberNeuro Omega with NeuroFortis Drive Headstage + 2
Catalog NumberNOW-NFF000-00
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
GS127290114063177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

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[27290114063177]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

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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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