NeuroNav Input Cable STR-000526-11

GUDID 17290014954110

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID17290014954110
NIH Device Record Keya1b813b6-fcc0-4884-a21e-8b2bf3b8dc99
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav Input Cable
Version Model Number1 channel
Catalog NumberSTR-000526-11
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
GS107290014954113 [Primary]
GS117290014954110 [Package]
Contains: 07290014954113
Package: cartoon [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 [NeuroNav Input Cable]

172900149542025 channels MER only
172900149541964 channels MER only
172900149541893 channels MER only
172900149541722 channels MER only
172900149541651 channel MER only
172900149541585 channels
172900149541414 channels
172900149541343 channels
172900149541272 channels
172900149541101 channel

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