HaGuide Software 407-000024-00

GUDID 07290114064965

HaGuide Software Version 6.2.0

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode
Primary Device ID07290114064965
NIH Device Record Key53040079-655c-4726-9d4d-9514520d04bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHaGuide Software
Version Model NumberHaGuide Software
Catalog Number407-000024-00
Company DUNS531856466
Company NameALPHA OMEGA ENGINEERING CO. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290114064965 [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 Date2026-03-23
Device Publish Date2026-03-13

On-Brand Devices [HaGuide Software]

07290114064071HaGuide Software
07290114064965HaGuide Software Version 6.2.0

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