NeuroNav Headstage cable 190-000375-00

GUDID 07290114063678

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290114063678
NIH Device Record Key8a496e3c-345e-4afc-b044-04a56264e0df
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav Headstage cable
Version Model NumberHeadstage cable
Catalog Number190-000375-00
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114063678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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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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