2x4" Rectangle Fabric Electrode

Basic Information

• Brand Name: 2x4" Rectangle Fabric Electrode
• Primary DI: 00860019001654
• Version / Model: SF50100WP
• Company Name: ELITE MEDICAL SUPPLY OF NY
• Labeler DUNS: 608469891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-14
• Public Version: 1
• Public Version Date: 2018-11-14
• Public Version Status: New
• Public Device Record Key: 2dd60f99-88d4-4f20-8479-658e6c851395

Device Description

2x4" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45208	Interferential electrical stimulation system electrode	A component of an interferential electrical stimulation system designed to conduct electrical currents from the system's pulse generator to specific areas of the body typically to treat pain. In interferential treatment it is typical to use two electrical conductors (electrodes) that are attached to the patient's skin at opposite corners of a square along which currents are delivered (e.g., 4000 and 41000 Hz) that interfere at its centre. This results in a beat frequency at the difference between the frequencies and this is used to treat muscle disorders or, at higher frequencies, to relieve pain. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860019001654	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Width	2	Inch