Axonics Accessory, Lead Extension Cable
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Basic Information
- Primary DI
- 10810005340288
- Basic UDI-DI Code
- B-10810005340288
- Reference
- 9009
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Percutaneous Extension is temporarily partially implanted cable that allows the electrical pulses generated by the EPG to be transferred to the sacral nerve via the implanted Permanent Lead. The Percutaneous Extension is used in the trial implantation period that lasts up to four weeks. Following appropriate placement of the Permanent Lead, the Percutaneous Extension is connected to the proximal end of the Permanent Lead and tunneled subcutaneously to connect to an EPG.
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
Similar Devices
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