Eu Aimdd Eu Aimdd Class On The Market πŸ‡ΊπŸ‡Έ United States

Axonics Lead Implant Kit

Axonics Inc. Β· πŸ‡ΊπŸ‡Έ United States
Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2

Basic Information

Primary DI
10810005340080
Basic UDI-DI Code
B-10810005340080
Reference
1801
Device Types
Single use Sterile Sterilization
Regulation
Eu Aimdd
Classification
Eu Aimdd Class
Status
On The Market
Manufacturer
Axonics Inc.

Additional Description

The Axonics Lead Implant Kit (also known as the Surgical Tool Kit) consists of surgical tools and accessories used to support the implantation of the Axonics Implantable Neurostimulator and Tined Lead (Model 1201). A set of the following parts are included this kit: Foramen Needle (with Needle Stylet), Directional Guide, Introducer Sheath and Dilator, Lead Stylet, Torque Wrench, Tunneling Tool, Needle Test Stimulation Cable and Lead Test stimulation cable.

CND Nomenclature Codes

Code Description
J020480 SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES

Certificates

Type Number
AIMDD Annex II (excluding section 4) 639686
AIMDD Annex II Section 4 634655

Available In Countries

πŸ‡³πŸ‡± Netherlands

Similar Devices

Other on-the-market devices with the same classification (Eu Aimdd Class) and regulation (EU AIMDD).

View all