N/A

Basic Information

• Brand Name: N/A
• Primary DI: EINO5326379
• Version / Model: 532637
• Company Name: inomed Medizintechnik GmbH
• Labeler DUNS: 340782259
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: ee473560-750a-4844-836e-011a0a5d0bb3
• Distribution End Date: 2022-12-12

Device Description

SDN electrodes Trigon RD/BK15 mm/2 m, 10 pcs.

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: 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
ETN	Stimulator, Nerve	Ear, Nose, Throat	874.1820	2
GWF	Stimulator, Electrical, Evoked Response	Neurology	882.1870	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	EINO5326379	HIBCC