NeuroNav Pelican Case 370-000090-00

GUDID 07290114061353

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system
Primary Device ID07290114061353
NIH Device Record Keyf3485ce8-e575-4d89-8ab4-3dd6481b6898
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroNav Pelican Case
Version Model Number1
Catalog Number370-000090-00
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

Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com
Phone+972545616253
Emaile.shamgar@alphaomega-eng.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114061353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-02
Device Publish Date2022-07-25

On-Brand Devices [NeuroNav Pelican Case]

072901140613531
27290114063702NeuroNav Pelican Case

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