Device
Disposable Subdermal Needle Electrode 13x0.38mm 2.5m twisted wire 16pairs
Manufacturer
Technomed Engineering B.V.
Technomed Engineering B.V.
Model: TE/S50722-003-K
DI: 08720791378868
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Disposable Subdermal Needle Electrode 13x0.38mm 2.5m twisted wire 16pairs
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5fe4a0e5-779b-4465-bf70-199c71d774e8
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
shelf box
Item #1 - Device ID:
08720791378851
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
16
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08720791378868
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08720791378868
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
GXZ
Electrode, Needle
IKT
Electrode, Needle, Diagnostic Electromyograph
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
0.38
Item #1 - Size Type:
Outer Diameter
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
13
Item #2 - Size Type:
Length