NeuroOmega Autoclavable 750-000025-00

GUDID 07290014954021

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290014954021
NIH Device Record Key0a96163f-2c1e-45a6-9bb9-bbf2ee2e828f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroOmega Autoclavable
Version Model NumberDrive-Head Stage
Catalog Number750-000025-00
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 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

Customer Support Contacts

Phone8779196288
Emailm.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014954021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290014954021]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-22
Device Publish Date2017-10-31

On-Brand Devices [NeuroOmega Autoclavable]

07290014954021Drive-Head Stage
07290014954014Drive

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