Neurosign V4

Basic Information

• Brand Name: Neurosign V4
• Primary DI: 08718375865125
• Version / Model: 4202-00
• 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: 2017-06-28
• Public Version: 3
• Public Version Date: 2021-05-06
• Public Version Status: Update
• Public Device Record Key: d36dac60-5847-4936-83ab-008249b3151e
• Distribution End Date: 2021-05-03

Device Description

Lantern Laryngeal Electrode 4/5mm

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

GMDN Terms

Code	Name	Definition	Implantable	Status
62208	Electromyographic endotracheal tube electrode	A sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718375865125	GS1
Package	08718375865200	GS1	Pouch	1	Not in Commercial Distribution	2021-05-03

Customer Contacts

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