FDA.reportPublic FDA data

HaGuide Software

Primary DI
07290114064071
Brand
HaGuide Software
Company
ALPHA OMEGA ENGINEERING CO. LTD.
Model
HaGuide Software
Catalog number
407-000024-00
Published
2022-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171581000Neuro Omega SystemAlpha Omega Engineering , Ltd.2017-12-22GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114064071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114064071072901140640717290114064071

GMDN Terms#

Term, Definition table
TermDefinition
Brain-responsive electrical stimulation systemAn assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531856466
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290114064965HaGuide SoftwareHaGuide Software407-000024-002026-03-13
27290114060879NeuroNav with MER HeadstageNeuroNav with MER HeadstageNNW-025023-552024-01-08
27290114061364NeuroNav Pelican CaseNeuroNav Pelican Case700-000888-002024-01-08
27290114061371Universal DBS holder silicone sleeve - Pack of 5Universal DBS holder silicone sleeve - Pack of 5341-011305-05 2024-01-08
27290114061388Universal LeadConfirm cable holder silicone sleeve - Pack of 5Universal LeadConfirm cable holder silicone sleeve341-011308-05 2024-01-08
37290114061408Frame adapter thumb screw - Pack of 3Frame adapter thumb screw - Pack of 3700-001330-032024-01-08
07290014954090Sterile electrode's cable Sterile electrode's cable STR-000664-002024-01-08
07290014954816Sterile electrode's cable Sterile electrode's cable STR-000664-112024-01-08
07290014954991Neuro Omega MER HeadstageNeuro Omega MER Headstage750-000023-002024-01-08
07290016450026NeuroNav MER HeadstageMER Headstage700-005023-002024-01-08
07290114060486Power cablePlug Type B 190-000117-012024-01-08
07290114060493Power cablePlug Type G190-000117-022024-01-08
07290114060509Power cablePlug Type J190-000117-032024-01-08
07290114060516Power cablePlug Type L-4mm190-000117-042024-01-08
07290114060523Power cablePlug Type M190-000117-052024-01-08
07290114060530Power cablePlug Type I190-000117-072024-01-08
07290114060547Power cablePlug Type F190-000117-082024-01-08
07290114060554Power cablePlug Type H190-000117-092024-01-08
07290114060561Neuro Omega NeuroFortis Drive HeadstageNeuro Omega NeuroFortis Drive Headstage750-000070-002024-01-08
07290114060820Power cablePlug Type D190-000117-122024-01-08

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Primary DI, Brand, Company table
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00650551005544DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005919DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005926DEPTHALON®PMT CORPORATIONGZL2026-05-15
00841823108814Anchor Bolt Kit, LSB StyleAd-Tech Medical Instrument CorporationGZL2026-04-08
10873263009625microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
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10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
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00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
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