Rochester

Basic Information

• Brand Name: Rochester
• Primary DI: 00849593015240
• Version / Model: NS-S94025-A-24SC
• Company Name: Advantage Medical Electronics, LLC
• Labeler DUNS: 080242300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-04-16
• Public Version: 2
• Public Version Date: 2023-02-10
• Public Version Status: Update
• Public Device Record Key: e54eb13f-2de1-4e3f-926a-73bd540083e0

Device Description

SPECIALTYCARE DISPOSABLE SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 2.5 M SINGLE LEADWIRE, COLOR GROUP A 24/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: Yes
• 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
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	00849593015240	GS1
Unit of Use	00849593010085	GS1

Customer Contacts

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