Neuro Omega Input Cable STR-000642-11

GUDID 17290014954219

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID17290014954219
NIH Device Record Key6090ef5b-210a-4879-9c33-d331da230448
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega Input Cable
Version Model Number1 channel
Catalog NumberSTR-000642-11
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
GS107290014954212 [Primary]
GS117290014954219 [Package]
Contains: 07290014954212
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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