NA

Basic Information

• Brand Name: NA
• Primary DI: 20643169290055
• Version / Model: 8227418
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-04-22
• Public Version: 5
• Public Version Date: 2021-01-12
• Public Version Status: Update
• Public Device Record Key: a11cf725-cee5-4fe2-b0ed-4eb7b693d93c

Device Description

ELECTRODE 8227418 5PK PRASS PRD 2CH ROHS

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: No
• Has Expiration Date: No
• 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
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	20643169290055	GS1
Unit of Use	00643169290051	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K850107	000

Device Sizes

Type	Value	Unit	Text
Length	18.0	Millimeter