NeuroNav with NeuroFortis Drive Headstage NNW-006010-55

GUDID 27290114062392

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114062392
NIH Device Record Key272575ff-62ec-4f23-9352-bfc3ec6624fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav with NeuroFortis Drive Headstage
Version Model NumberNeuroNav with NeuroFortis Drive Headstage
Catalog NumberNNW-006010-55
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
GS127290114062392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


[27290114062392]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-22
Device Publish Date2023-05-14

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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