Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Lead Implant Kit
Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
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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 | Notified Body | Status |
|---|---|---|---|
| AIMDD Annex II (excluding section 4) | 639686 | BSI Group The Netherlands B.V. | |
| AIMDD Annex II Section 4 | 634655 | BSI Group The Netherlands B.V. |
Available In Countries
๐ณ๐ฑ Netherlands
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