Axonics 2301

GUDID 10810005340103

Remote Control

AXONICS MODULATION TECHNOLOGIES, INC.

Implantable incontinence-control electrical stimulation system programmer, battery-powered
Primary Device ID10810005340103
NIH Device Record Key602f08a3-8e4f-4460-b769-26623bb0d121
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxonics
Version Model Number2301
Catalog Number2301
Company DUNS079562449
Company NameAXONICS MODULATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110810005340103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, Electrical, Implantable, For Incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [Axonics]

10810005340387Charging Device
10810005340370Charging Station
10810005340325Basic Trial Cable
10810005340301Dilator and Sheath
10810005340288Percutaneous Extension
10810005340271Charging Belt - Extended
10810005340264Charging Belt - Regular
10810005340257Tined Lead Test Stim. Cable
10810005340240Needle Test Stim. Cable
10810005340233Carrier
10810005340226Torque Wrench
10810005340219Stimulation Ground Cables
10810005340196Foramen Needle - Long
10810005340189Foramen Needle - Short
10810005340158Tined Lead
10810005340141Tined Lead Kit
10810005340134PNE Lead Implant Kit
10810005340127PNE Lead
10810005340103Remote Control
10810005340080Lead Implant Kit
10810005340066Neurostimulator
10810005340059Trial Stimulator
10810005340035Clinician Programmer
10810005340028Clinician Programmer
10810005340011Charging System
10810005340431Curved Charging Belt - Extended
10810005340424Curved Charging Belt - Regular
10810005340455Neurostimulator
10810005340486Curved Stylet
10810005340479Neurostimulator

Trademark Results [Axonics]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AXONICS
AXONICS
97565339 not registered Live/Pending
AXONICS, INC
2022-08-25
AXONICS
AXONICS
86309695 4893460 Live/Registered
Axonics Modulation Technologies, Inc.
2014-06-13
AXONICS
AXONICS
77329931 3466754 Live/Registered
Axonics, Inc.
2007-11-14
AXONICS
AXONICS
73505138 1340485 Dead/Cancelled
AXONICS, INC.
1984-10-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.