Technomed Europe

Basic Information

• Brand Name: Technomed Europe
• Primary DI: 08718375861660
• Version / Model: TE/S51-634
• Company Name: Technomed Engineering B.V.
• Labeler DUNS: 418415568
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2025-02-17
• Public Version Status: Update
• Public Device Record Key: 86acc288-2fa1-4f23-83bd-d65f54087ff8
• Distribution End Date: 2022-03-08

Device Description

Reusable Subdermal Needle Electrode, 2 x 6 colors, 1.5m wire, 12 pieces

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization, Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	890.1385	2
GXZ	Electrode, Needle	Neurology	882.1350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47710	Electromyographic needle electrode, reusable	An 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 reusable device after sterilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718375861660	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Needle Gauge	27	Gauge
Outer Diameter	0.4	Millimeter
Length	13	Millimeter