Neuroline Twisted Pair SubdermalNeurology Needle Electrodes

Basic Information

• Brand Name: Neuroline Twisted Pair SubdermalNeurology Needle Electrodes
• Primary DI: 05707480038848
• Version / Model: 74612-100/2/20
• Catalog Number: 74612-100/2/20
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 23e0327c-24ec-442a-82d7-dd29d7c41274

Device Description

Ambu Neuroline Twisted Part Subdermal Needle Electrode Length: 12 mm (0.5") Leadwire Length: 100 cm (40") Black is paired with 5 different colours (purple, grey, dark red, pink, beige) 2 x 10 pairs of needles/2 pouches/1 box

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
IKT	Electrode, needle, diagnostic electromyograph	Physical Medicine	890.1385	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
Package	05707480038862	GS1		8	Not in Commercial Distribution	2018-03-09
Package	05707480038855	GS1		20	Not in Commercial Distribution	2018-03-09
Primary	05707480038848	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	100	Centimeter
Length	12	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius