Axonics 1601

GUDID 10810005340059

Trial Stimulator

AXONICS MODULATION TECHNOLOGIES, INC.

Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator

• Primary Device ID: 10810005340059
• NIH Device Record Key: 5b0494e1-6ad7-4572-b6e0-e255715aa5a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axonics
• Version Model Number: 1601
• Catalog Number: 1601
• Company DUNS: 079562449
• Company Name: AXONICS MODULATION TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810005340059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190006

FDA Product Code

• EZW: Stimulator, Electrical, Implantable, For Incontinence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [Axonics]

• 10810005340387: Charging Device
• 10810005340370: Charging Station
• 10810005340325: Basic Trial Cable
• 10810005340301: Dilator and Sheath
• 10810005340288: Percutaneous Extension
• 10810005340271: Charging Belt - Extended
• 10810005340264: Charging Belt - Regular
• 10810005340257: Tined Lead Test Stim. Cable
• 10810005340240: Needle Test Stim. Cable
• 10810005340233: Carrier
• 10810005340226: Torque Wrench
• 10810005340219: Stimulation Ground Cables
• 10810005340196: Foramen Needle - Long
• 10810005340189: Foramen Needle - Short
• 10810005340158: Tined Lead
• 10810005340141: Tined Lead Kit
• 10810005340134: PNE Lead Implant Kit
• 10810005340127: PNE Lead
• 10810005340103: Remote Control
• 10810005340080: Lead Implant Kit
• 10810005340066: Neurostimulator
• 10810005340059: Trial Stimulator
• 10810005340035: Clinician Programmer
• 10810005340028: Clinician Programmer
• 10810005340011: Charging System
• 10810005340431: Curved Charging Belt - Extended
• 10810005340424: Curved Charging Belt - Regular
• 10810005340455: Neurostimulator
• 10810005340486: Curved Stylet
• 10810005340479: Neurostimulator
• 10810005340578: PE & Torque Wrench