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
08906035281044Ambu WhiteSensor0415M2020-08-20
08906035281174Ambu WhiteSensor3245D/RT/602020-08-20
08906035281501Ambu WhiteSensor0715M2020-08-20
08906035281525Ambu WhiteSensor0315M2020-08-20
08906035281532Ambu WhiteSensor0215M2020-08-20
08906035281549Ambu WhiteSensor0615M2020-08-20
08906035281587Ambu WhiteSensor4500M-H/32020-08-20
08906035281600Ambu WhiteSensor4535M2020-08-20
08906035282829Ambu WhiteSensorWS-00-S/502020-08-20
08906035282881Ambu WhiteSensor4500M2020-08-20
08906035282898Ambu WhiteSensor4560M2020-08-20
08906035282904Ambu WhiteSensor4570M2020-08-20
08906035282911Ambu WhiteSensor4500M-H2020-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17