FDA.reportPublic FDA data

MediMax Tech

Primary DI
20817325020248
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
BH2530P Needle Electrodes
Device description
BH2530P Needle Electrodes - Hypodermic Needle, Prewired, 25mm Length, 0.30mm(30G) Diameter.
Published
2016-08-12
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

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
10817325020241PackageGS110In Commercial Distribution
20817325020248PackageGS120In Commercial Distribution
00817325020244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502024110817325020241
2081732502024820817325020248
00817325020244008173250202448173250202440817325020244

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00817325025010iChopperIC-27G2026-04-30
00817325023764MediMax TechPSF22020-09-24
00817325023771MediMax TechASF32020-09-24
00817325023788MediMax TechASFN32020-09-24
00817325023795MediMax TechASFT032020-09-24
00817325023801MediMax TechTS32020-11-16
00817325023818MediMax TechTV32020-11-16
00817325023825MediMax TechTO3 2020-11-16
00817325026574MediMaxTech Inc.MSH22M2024-03-25
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
00817325020381MediMax TechNCS-SG15 Surface Electrodes2016-08-19
00817325020398MediMax TechMF2409 Surface Electrodes2016-08-19
00817325020350MediMax TechSG15R Surface Electrodes2016-08-19
00817325020367MediMax TechSG15G Surface Electrodes2016-08-19
00817325022729MediMax TechSG15G Surface Electrodes- 5 pc Sample Pack2017-01-18
00817325020695MediMax TechInnostim Tens 1k Unit2016-08-02

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Primary DI, Brand, Company table
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08720791377656CadwellTechnomed Engineering B.V.GXZ2025-05-26
08720791377670CadwellTechnomed Engineering B.V.GXZ2025-05-26
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
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10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
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08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
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08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
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08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
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10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26