FDA.reportPublic FDA data

Power cable

Primary DI
07290114060530
Brand
Power cable
Company
ALPHA OMEGA ENGINEERING CO. LTD.
Model
Plug Type I
Catalog number
190-000117-07
Published
2024-01-08
Public version status
New
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
07290114060530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114060530072901140605307290114060530

GMDN Terms#

Term, Definition table
TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.

Regulatory Flags#

DUNS number
531856466
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
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
07290114060844Power cablePlug Type K190-000117-142024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551005537DEPTHALON®PMT CORPORATIONGZL2026-05-18
00650551006138DEPTHALON®PMT CORPORATIONGZL2026-05-18
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
00873263009611microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
00841823110831Spencer Probe Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-11-07
10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
00873263009420microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
10873263008789microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008796microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008802microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008819microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008826microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008833microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008840microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008857microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008871microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
10873263008888microTargeting™ ElectrodeFHC, INC.GZL2025-04-30
10873263008918microTargeting™ Electrode and Insertion Tube KitFHC, INC.GZL2025-04-30
00856895008634OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
00856895008641OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
00873263009239microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
00873263009246microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12