Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics PNE Lead Implant Kit
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340134
- Basic UDI-DI Code
- B-10810005340134
- Reference
- 1701
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
PNE Lead Implant Kit (Model 1701) provides all the components necessary to implant PNE Lead (Model 1901) for the trial stimulation period including standard sterile hospital grade surgical accessories and non-sterile ground pads.
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. |
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