Eu Aimdd Eu Aimdd Class On The Market πŸ‡ΊπŸ‡Έ United States

Axonics Accessory, Lead Extension Cable

Axonics Inc. Β· πŸ‡ΊπŸ‡Έ United States
Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2

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
AIMDD Annex II (excluding section 4) 639686
AIMDD Annex II Section 4 634655

Available In Countries

πŸ‡³πŸ‡± Netherlands

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