Disposable Adhesive Surface Electrodes

Basic Information

• Brand Name: Disposable Adhesive Surface Electrodes
• Primary DI: 18054655005155
• Version / Model: CDER2490F4
• Company Name: SPES MEDICA SRL
• Labeler DUNS: 514029771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 120
• Record Status: Published
• Publish Date: 2016-06-21
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fc1aaf4b-107a-483c-b89d-cefa27f5a6f4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18054655005155	GS1
Unit of Use	08054655005158	GS1

Premarket Submissions

Submission Number	Supplement Number
K120494	000