FDA.reportPublic FDA data

Medico Electrodes/ Neutralect

Primary DI
18904450905764
Brand
Medico Electrodes/ Neutralect
Company
MEDICO ELECTRODES INTERNATIONAL LIMITED
Model
NE135101WX
Device description
Electrosurgical Neutral Electrodes are used to complete the circuit during electrosurgical procedures in conjunction with the electrical generator and the active electrode. They are used to provide safe electrical contact to the patient during electrosurgical procedures.
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955261000NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)Msb , Ltd.1996-01-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18904450905764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1890445090576418904450905764

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Regulatory Flags#

DUNS number
677425215
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18904450905740Medico Electrodes/ NeutralectNE135101X2026-04-17
18904450905757Medico Electrodes/ NeutralectNE135101SX2026-04-17
18904450905771Medico Electrodes/ NeutralectNE135101SWX2026-04-17
18904450905788Medico Electrodes/ NeutralectNE189106X2026-04-17
18904450905795Medico Electrodes/ NeutralectNE189106SX2026-04-17
18904450905801Medico Electrodes/ NeutralectNE189106WX2026-04-17
18904450905818Medico Electrodes/ NeutralectNE189106SWX2026-04-17
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Primary DI, Brand, Company table
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