NeuroSmart with AutoClavable Drive Headstage (AutoClavable) NSW-006008-55

GUDID 27290114063306

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114063306
NIH Device Record Key1f9de5c2-7b78-4b06-934e-f3b9434e3cb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart with AutoClavable Drive Headstage (AutoClavable)
Version Model NumberNeuroSmart with AutoClavable Drive Headstage (Auto
Catalog NumberNSW-006008-55
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
GS127290114063306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


[27290114063306]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

07290114064057 - Remote Control2024-01-12
07290114064064 - Remote Control2024-01-12
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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