Neuro Omega ECOG HeadBox Kit 750-020016-00

GUDID 27290114063207

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID27290114063207
NIH Device Record Key4df38861-5249-4103-bdc5-147dcab171b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro Omega ECOG HeadBox Kit
Version Model NumberNeuro Omega ECOG HeadBox Kit
Catalog Number750-020016-00
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
GS127290114063207 [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 ECOG HeadBox Kit]

27290114060800Neuro Omega ECOG HeadBox Kit
27290114063207Neuro Omega ECOG HeadBox Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.