FDA.reportPublic FDA data

Technomed Europe

Primary DI
08718375867785
Brand
Technomed Europe
Company
Technomed Engineering B.V.
Model
TE/S46-638/01
Device description
Disposable Subdermal Needle Electrode 12x0.4mm Pt/Ir 1.36m wire 5x5 colors 25pcs
Published
2020-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718375866924PackageGS125In Commercial Distribution
08718375867785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718375866924087183758669248718375866924
08718375867785087183758677858718375867785

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
Length12Millimeter
Needle Gauge27Gauge
Outer Diameter0.4Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
418415568
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08720791377717Inomed5256212025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.GXZ2021-06-02
08718375867129NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867143NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867167NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867181NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867204NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867228NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867242NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867266NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867280NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867303NatusTechnomed Engineering B.V.GXZ2021-04-01
08718375867556Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867907Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867914Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867921Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867938Technomed EuropeTechnomed Engineering B.V.GXZ2021-02-24
08718375867945Technomed EuropeTechnomed Engineering B.V.GXZ2021-01-20
08718375867969Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867983Neurosign V4Technomed Engineering B.V.GXZ2021-01-12
08718375867327Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867341Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375867365Technomed EuropeTechnomed Engineering B.V.GXZ2020-12-08
08718375866672Neurosign V4Technomed Engineering B.V.GXZ2020-07-22