BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

NA

DI: 20643169695041 · Model: 8227418 · MEDTRONIC XOMED, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

5

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Basic Information

Brand Name: NA
Primary DI: 20643169695041
Version / Model: 8227418
Company Name: MEDTRONIC XOMED, INC.
Labeler DUNS: 835465063
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 5
Record Status: Published
Publish Date: 2016-08-15
Public Version: 6
Public Version Date: 2024-06-10
Public Version Status: Update
Public Device Record Key: 34aed7b3-63e7-44cd-9616-c3d113e2245b
Distribution End Date: 2023-12-06

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	20643169695041	GS1
Unit of Use	00643169695047	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K850107	000

Device Sizes

Type	Value	Unit	Text
Length	18.0	Millimeter