FDA.reportPublic FDA data

Technomed Europe

Primary DI
08720791375539
Brand
Technomed Europe
Company
Technomed Engineering B.V.
Model
TE/S50725-004-C
Device description
Disposable Subdermal Needle Electrode corkscrew 1.5m twisted wire 12pairs & PC
Published
2025-01-07
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
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241045000Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe2024-12-11GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720791375539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720791375539087207913755398720791375539

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.2Meter
Needle Gauge23Gauge
Outer Diameter0.6Millimeter

Sterilization Methods#

Method table
Method

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
08720791378172Technomed EuropeCS-SG01102026-07-08
08720791378189Technomed EuropeCS-SG02102026-07-08
08720791378196Technomed EuropeCS-SG03102026-07-08
08720791378202Technomed EuropeCS-SG01152026-07-08
08720791378219Technomed EuropeCS-SG02152026-07-08
08720791378226Technomed EuropeCS-SG03152026-07-08
08720791378233Technomed EuropeCS-SG01202026-07-08
08720791378240Technomed EuropeCS-SG02202026-07-08
08720791378257Technomed EuropeCS-SG03202026-07-08
08720791378264Technomed EuropeCS-SG01252026-07-08
08720791378271Technomed EuropeCS-SG02252026-07-08
08720791378288Technomed EuropeCS-SG03252026-07-08
08720791378295Technomed EuropeCS-ARR21102026-07-08
08720791378301Technomed EuropeCS-ARR23102026-07-08
08720791378318Technomed EuropeCS-ARR25102026-07-08
08720791378325Technomed EuropeCS-ARR27102026-07-08
08720791378332Technomed EuropeCS-ARR21152026-07-08
08720791378349Technomed EuropeCS-ARR23152026-07-08
08720791378356Technomed EuropeCS-ARR25152026-07-08
08720791378363Technomed EuropeCS-ARR27152026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.GXZ2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08718375869062AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869154AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869307AmbuTechnomed Engineering B.V.GXZ2022-07-04
08718375869338AmbuTechnomed Engineering B.V.GXZ2022-07-04
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