Axonics

Basic Information

• Brand Name: Axonics
• Primary DI: 10810005340141
• Version / Model: 1201
• Catalog Number: 1201
• 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: 2
• Public Version Date: 2020-04-06
• Public Version Status: Update
• Public Device Record Key: 97478016-b075-48cb-af9d-d02078fb4009

Device Description

Tined Lead Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
44045	Sacral plexus implantable incontinence-control electrical stimulation system electrode	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810005340141	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P190006	000