Device
Disposable Concentric Needle Electrode, Green
Manufacturer
Technomed Engineering B.V.
Technomed Engineering B.V.
Model: TE/B50700-003
DI: 08720791378110
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Disposable Concentric Needle Electrode, Green
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bfe01b13-0992-4db6-aac2-b7495f36633a
Distribution Status:
In Commercial Distribution
DUNS Number:
418415568
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
08720791378103
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08720791378110
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08720791378110
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 11441
Name: Electromyographic needle electrode, single-use
Definition:
A 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.
FDA Product Codes
IKT
Electrode, Needle, Diagnostic Electromyograph
GXZ
Electrode, Needle