FDA.reportPublic FDA data

MediMax Tech

Primary DI
20817325020040
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
BC3028 Needle Electrodes
Device description
BC3028 Needle Electrodes - Concentric Needle, Non-Wired, 30mm Length, 0.36mm(28G) 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

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
10817325020043PackageGS125In Commercial Distribution
20817325020040PackageGS18In Commercial Distribution
00817325020046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502004310817325020043
2081732502004020817325020040
00817325020046008173250200468173250200460817325020046

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
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
10817325023792MediMax TechASFT032020-09-24
10817325023761MediMax TechPSF22020-09-24
10817325023778MediMax TechASF32020-09-24
10817325023785MediMax TechASFN32020-09-24
20817325023638MediMax TechSPDE-SL52019-12-02
20817325023652MediMax TechSPDEI-SL52019-12-02
20817325023683MediMax TechSPEC-SL52019-12-02
20817325023706MediMax TechSPECI-SL52019-12-02
20817325023720MediMax TechSPST-SL52019-12-02
20817325023744MediMax TechSPSTI-SL52019-12-02
20817325023621MediMax TechSPDE-SL2019-12-02
20817325023645MediMax TechSPDEI-SL2019-12-02
20817325023669MediMax TechSPEC-SL2019-12-02
20817325023690MediMax TechSPECI-SL2019-12-02
20817325023713MediMax TechSPST-SL2019-12-02
20817325023737MediMax TechSPSTI-SL2019-12-02

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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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00816312027730Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-16
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10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-05-05
10841019116910KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-07
10841019122409KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122416KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
10841019122423KirwanKIRWAN SURGICAL PRODUCTS LLCGXZ2025-04-04
08720791374587NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374600NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374624NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374648NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374662NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791374686NeurosignTechnomed Engineering B.V.GXZ2025-02-28
08720791375706CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375720CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375744CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375768CadwellTechnomed Engineering B.V.GXZ2025-02-28
08720791375782CadwellTechnomed Engineering B.V.GXZ2025-02-28
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2025-02-26