Technomed Europe

Basic Information

• Brand Name: Technomed Europe
• Primary DI: 08718375866092
• Version / Model: TE/Q95-931
• Company Name: Technomed Engineering B.V.
• Labeler DUNS: 418415568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-10
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 61a5b796-6c68-49c5-a671-e01ee5b33fb8

Device Description

Disposable Stimulation Clip, Sterile 5-22mm

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35750	Analytical non-scalp cutaneous lead	An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08718375866108	GS1	Shelfbox	1	In Commercial Distribution
Primary	08718375866092	GS1

Customer Contacts

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