NA

Basic Information

• Brand Name: NA
• Primary DI: 20613994801405
• Version / Model: DSE1115
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2016-04-30
• Public Version: 4
• Public Version Date: 2021-02-24
• Public Version Status: Update
• Public Device Record Key: 97ecebbb-f362-4eab-b86d-9bf7fef2d94a

Device Description

ELECTRODE DSE1115 48PK 15X20MM 1.5M 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
GWE	STIMULATOR, PHOTIC, EVOKED RESPONSE	Neurology	882.1890	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	20613994801405	GS1
Unit of Use	00613994801401	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061639	000

Device Sizes

Type	Value	Unit	Text
Length	20.0	Millimeter
Length	1.5	Meter
Width	15.0	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit