N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04250307609857
• Version / Model: 532654
• Company Name: inomed Medizintechnik GmbH
• Labeler DUNS: 340782259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-22
• Public Version: 2
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: d0f8ce67-3490-45a7-bd8d-9a8d3fc2ac85

Device Description

SDN electrode Trigon BK 20/3000, stainless steel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
GWF	Stimulator, Electrical, Evoked Response	Neurology	882.1870	2
ETN	Stimulator, Nerve	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61089	Nerve-locating system probe, single-use	A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250307609857	GS1