Neuro Omega with NeuroOmega Drive NOW-020021-00

GUDID 27290016450839

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290016450839
NIH Device Record Keyfab32d27-3bf0-462a-a76e-f2734af99313
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega with NeuroOmega Drive
Version Model NumberNeuro Omega with NeuroOmega Drive
Catalog NumberNOW-020021-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
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
GS127290016450839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290016450839]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-22
Device Publish Date2019-08-20

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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