Axonics

Basic Information

• Brand Name: Axonics
• Primary DI: 10810005340301
• Version / Model: 9011
• Catalog Number: 9011
• Company Name: AXONICS MODULATION TECHNOLOGIES, INC.
• Labeler DUNS: 079562449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-09-23
• Public Version: 3
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: a4ac1609-b398-414c-9600-9f6895d89746

Device Description

Dilator and Sheath

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: 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
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810005340301	GS1
Unit of Use	00810005340304	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P190006	000