Device
Disposable Concentric Needle Electrode, Blue
Manufacturer
Technomed Engineering B.V.
Technomed Engineering B.V.
Model: TE/B50700-004
DI: 08720791378134
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, Blue
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
18a3f794-c217-4a7b-9265-c3ec7b1ca36d
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:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08720791378134
Type:
Primary
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
GXZ
Electrode, Needle
IKT
Electrode, Needle, Diagnostic Electromyograph