FDA.reportPublic FDA data

Neuroguard

Primary DI
08720791375140
Brand
Neuroguard
Company
Technomed Engineering B.V.
Model
S23-837
Device description
Disposable Subdermal Needle Electrode 22x0.38mm 2m parallel wire 8pair
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720791375140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720791375140087207913751408720791375140

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
+31434086868info@technomed.nl

Regulatory Flags#

DUNS number
418415568
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720791375164NeuroguardS23-9372026-06-05
08720791379032Technomed EuropeTE/C53-10382026-06-03
08720791379049Technomed EuropeTE/C53-10322026-06-03
08720791379063Technomed EuropeTE/K50440-0012026-06-03
08720791379087Technomed EuropeTE/K50440-0152026-06-03
08718375867037Cadwell302296-000-0202020-11-13
08720791378165NeurosignNM-Kit 22026-04-30
08720791378790Technomed Europe8735-00502026-04-30
08720791378806Technomed Europe8735-00602026-04-30
08720791378813Technomed EuropeTE/Q96-8322026-04-30
08720791378837Technomed EuropeBTP2.3-160/12026-04-30
08720791378868Technomed EuropeTE/S50722-003-K2026-04-30
08720791378059Technomed EuropeTE/B50700-0012026-04-29
08720791378073Technomed EuropeTE/B50700-0022026-04-29
08720791378097Technomed EuropeTE/B50700-0062026-04-29
08720791378110Technomed EuropeTE/B50700-0032026-04-29
08720791378134Technomed EuropeTE/B50700-0042026-04-29
08720791378158Technomed EuropeTE/B50700-0052026-04-29
08720791379100Neuralytix NTX-90092026-04-28
08720791377700Inomed5256202025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08718375861707Technomed EuropeTechnomed Engineering B.V.GXZ2019-11-21
08033315122299BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122312BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122336BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122350BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122374BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122398BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122411BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122442BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122466BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122541BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122565BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122589BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122602BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122626BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122640BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122664BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122688BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08718375861714Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861721Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861738Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861745Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861752Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861769Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861899Technomed EuropeTechnomed Engineering B.V.IKT2016-09-22
08718375861899Technomed EuropeTechnomed Engineering B.V.GXZ2016-09-22
08718375861905Technomed EuropeTechnomed Engineering B.V.GXZ2016-09-22