FDA.reportPublic FDA data

NeuroProbe

Primary DI
17290014954882
Brand
NeuroProbe
Company
ALPHA OMEGA ENGINEERING CO. LTD.
Model
Non-shielded
Catalog number
366-222291-00
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052527000NEUROPROBESAlpha Omega Engineering , Ltd.2006-04-12GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290014954882PackageGS110In Commercial Distribution
07290014954885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001495488217290014954882
07290014954885072900149548857290014954885

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8779196288m.andrea@alphaomega-eng.com

Regulatory Flags#

DUNS number
531856466
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006749DEPTHALON®PMT CORPORATIONGZL2026-06-09
00841823111029Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2026-06-03
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
10873263009496microTargeting™ ElectrodeFHC, INC.GZL2025-12-02
00841823110831Spencer Probe Depth ElectrodeAd-Tech Medical Instrument CorporationGZL2025-11-07
10873263009410microTargeting™ 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
10873263009205microTargeting™ ElectrodeFHC, INC.GZL2024-04-12
03664539003900NADIXI MEDICALGZL2024-04-03
03664539003917NADIXI MEDICALGZL2024-04-03