NeuroSmart with NeuroFortis Drive NSW-026010-55

GUDID 27290114060435

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114060435
NIH Device Record Keyc14ba8c0-020c-43ac-b646-4eb6b86883d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuroSmart with NeuroFortis Drive
Version Model NumberNeuroSmart with NeuroFortis Drive
Catalog NumberNSW-026010-55
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS127290114060435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[27290114060435]

Hydrogen Peroxide


[27290114060435]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

On-Brand Devices [NeuroSmart with NeuroFortis Drive ]

27290016450082NeuroSmart with NeuroFortis Drive
27290114060435NeuroSmart with NeuroFortis Drive

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