Horizon™

Basic Information

• Brand Name: Horizon™
• Primary DI: 10816843022201
• Version / Model: S91090-50
• Company Name: ROCHESTER ELECTRO-MEDICAL, INC.
• Labeler DUNS: 068156330
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-05-21
• Public Version Status: Update
• Public Device Record Key: d8a95f02-7bdb-48f8-864f-21a0d499d9db
• Distribution End Date: 2019-05-20

Device Description

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	10816843022201	GS1
Package	10816843022195	GS1		50	Not in Commercial Distribution	2019-05-20

Customer Contacts

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