NURO™

Basic Information

• Brand Name: NURO™
• Primary DI: 00643169654624
• Version / Model: 3533
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 54caaf37-8802-47b9-82a4-7835df83fd2e

Device Description

ENS 3533 NURO EXTERNAL NEUROSTIMULATOR

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: Yes
• Has Lot/Batch Number: No
• 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
NAM	STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION	Gastroenterology, Urology	876.5310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47028	Tibial nerve percutaneous incontinence-control electrical stimulation system	An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169654624	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132561	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius