NeuroNav Drive 700-006010-00

GUDID 07290014954939

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290014954939
NIH Device Record Key0608e7d6-4964-47e6-8bc4-6553ed500542
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav Drive
Version Model NumberNeuroNav Drive
Catalog Number700-006010-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
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

Phone1-877-919-6288
Emailm.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014954939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290014954939]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-22
Device Publish Date2018-02-06

On-Brand Devices [NeuroNav Drive]

07290014954939NeuroNav Drive
07290014954069NeuroNav Drive

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