FDA.report

MediMax Tech

Primary DI
20817325020002
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
BC2530 Needle Electrodes
Device description
BC2530 Needle Electrodes - Concentric Needle, Non-Wired, 25mm Length, 0.30mm(30G) Diameter.
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications

CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817325020005PackageGS125In Commercial Distribution
20817325020002PackageGS18In Commercial Distribution
00817325020008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502000510817325020005
2081732502000220817325020002
00817325020008008173250200088173250200080817325020008

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
855-633-4629malorie.c@medimaxtech.com

Regulatory Flags

DUNS number
927071162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08720791378530CadwellTechnomed Engineering B.V.IKT2025-12-10
08720791378011CadwellTechnomed Engineering B.V.IKT2025-07-16
08720791378035CadwellTechnomed Engineering B.V.IKT2025-07-15
08720791375911CadwellTechnomed Engineering B.V.IKT2025-03-12
08054655008418Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08054655023350Disposable EMG needle electrodesSPES MEDICA SPAIKT2025-03-03
08720791376642CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376680CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791376727CadwellTechnomed Engineering B.V.IKT2025-02-12
08720791377861CadwellTechnomed Engineering B.V.IKT2025-01-16
08720791375232Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375256Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375355Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375379Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375393Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375416Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375478Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791375515Technomed EuropeTechnomed Engineering B.V.IKT2025-01-07
08720791377229Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377243Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377267Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377281Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377304Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377328Technomed EuropeTechnomed Engineering B.V.IKT2024-11-15
08720791377335CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377342CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377359CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377366CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377373CadwellTechnomed Engineering B.V.IKT2024-11-15
08720791377380CadwellTechnomed Engineering B.V.IKT2024-11-15