Neurosign

Basic Information

• Brand Name: Neurosign
• Primary DI: 08720791370770
• Version / Model: 5989-00
• Company Name: Technomed Engineering B.V.
• Labeler DUNS: 418415568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: bbc924be-25ae-401a-a783-7954cf807aee

Device Description

Disposable Pedicle Screw Probe 2.3mm ball x 255mm electrode; 1.9m wire with DIN42802 connector

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: 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
GXZ	Electrode, Needle	Neurology	882.1350	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
Package	08720791370787	GS1	Pouch	1	In Commercial Distribution
Primary	08720791370770	GS1

Customer Contacts

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