Axonics

Basic Information

• Brand Name: Axonics
• Primary DI: 10810005340059
• Version / Model: 1601
• Catalog Number: 1601
• Company Name: AXONICS MODULATION TECHNOLOGIES, INC.
• Labeler DUNS: 079562449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-23
• Public Version: 1
• Public Version Date: 2019-10-01
• Public Version Status: New
• Public Device Record Key: 5b0494e1-6ad7-4572-b6e0-e255715aa5a8

Device Description

Trial Stimulator

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	876.5270	3

GMDN Terms

Code	Name	Definition	Implantable	Status
61392	Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator	A portable, external battery-powered component of a sacral plexus percutaneous incontinence-control electrical stimulation system, intended to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via percutaneous electrodes (not included). It may be self-controlled or controlled by a separate external programmer. It is typically used during a trial period (<30days) to validate the therapy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810005340059	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P190006	000