Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot NOW-DF0000-00

GUDID 27290114060770

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060770
NIH Device Record Keyf42e8194-7589-4bba-bef5-dcc421a9e682
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega with Neuro Omega drive + 1 basic stimulation Slot
Version Model NumberNeuro Omega with Neuro Omega drive + 1 basic stimu
Catalog NumberNOW-DF0000-00
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 Kittrue
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
GS127290114060770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060770]

Hydrogen Peroxide


[27290114060770]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

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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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