Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Accessory Dilator and Sheath
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340301
- Basic UDI-DI Code
- B-10810005340301
- Reference
- 9011
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Accessories Kit provide individually packaged surplus components of the Axonics Sacral Neuromodulation System. These components are used in the implantation and operation of the Axonics Sacral Neuromodulation System . Refer to the appropriate product manual for each accessory for the instructions for use, indications, warning, and precautions, and additional information.
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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