Neuro Omega Input Cable STR-000666-44

GUDID 07290014954298

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290014954298
NIH Device Record Keyeeb9876d-0933-471a-bbd8-c1462fb112ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega Input Cable
Version Model Number4 channels MER only
Catalog NumberSTR-000666-44
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

Customer Support Contacts

Phone8779196288
Emailm.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014954298 [Primary]
GS117290014954295 [Package]
Package: carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-22
Device Publish Date2016-09-24

On-Brand Devices [Neuro Omega Input Cable ]

072900149543045 channels MER only
072900149542984 channels MER only
072900149542813 channels MER only
072900149542742 channels MER only
072900149542671 channel MER only
072900149542505 channels
172900149542404 channels
172900149542333 channels
172900149542262 channels
172900149542191 channel

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