Technomed Europe

Basic Information

• Brand Name: Technomed Europe
• Primary DI: 08720791376024
• Version / Model: TE/S50725-004
• Company Name: Technomed Engineering B.V.
• Labeler DUNS: 418415568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-23
• Public Version: 2
• Public Version Date: 2025-02-17
• Public Version Status: Update
• Public Device Record Key: b5e94312-8e1a-49f7-8396-e68db5263c2f

Device Description

Disposable Subdermal Needle Electrode corkscrew 1.5m twisted wire 12pairs

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
47714	Subdermal needle electrode	A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720791376024	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge
Outer Diameter	0.6	Millimeter
Length	1.5	Meter