Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Tined Lead
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340141
- Basic UDI-DI Code
- B-10810005340141
- Reference
- 1201
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Axonics Tined Lead (Model 1201) has four (4) electrode contacts to provide stimulation. The distal tip is implanted through the applicable foramen near the S3 sacral nerve with the proximal end connected to the Neurostimulator. Tines on the lead facilitate fixation of the lead just posterior to the sacral foramen.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J020403 | SACRAL SPINE NEUROSTIMULATION LEADS |
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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