Axonics

Basic Information

• Brand Name: Axonics
• Primary DI: 10810005340189
• Version / Model: 9001-S
• Catalog Number: 9001-S
• 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: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 7e4124f1-402a-47fc-9410-d3c6f2278dcf

Device Description

Foramen Needle - Short

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
63345	Electrical impedance navigation spinal needle	A sharp bevel-edged, hollow tubular metal instrument designed to be used: 1) as a bipolar electrode for real-time bioimpedance-based prediction of the needle tip location; and 2) for lumbar puncture/intrathecal injection. The needle and an included insulated stylet are intended to function as a bipolar electrode whereby tissue at the tip bridges the circuit; electrical signals and subsequent impedance values are interpreted by a navigational unit (not included) to identify tip location, and to confirm contact with cerebrospinal fluid (CSF). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810005340189	GS1
Unit of Use	00810005340182	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P190006	000