Neuro Omega EMG HeadBox Kit 750-020013-00

GUDID 27290114063214

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114063214
NIH Device Record Key8c5fb496-9e5b-4344-8309-bb4616b31020
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega EMG HeadBox Kit
Version Model NumberNeuro Omega EMG HeadBox Kit
Catalog Number750-020013-00
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

Device Identifiers

Device Issuing AgencyDevice ID
GS127290114063214 [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 Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [Neuro Omega EMG HeadBox Kit]

27290114060817Neuro Omega EMG HeadBox Kit
27290114063214Neuro Omega EMG HeadBox Kit

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