directSTIM 12-electrode lead

Organization name

Aleva Neurotherapeutics SA

SRN

CH-MF-000015804

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

directSTIM 12-electrode lead

UDI-DI code

07640183760013

Basic UDI-DI

B-07640183760013

Reference / catalog number

11500

Issuing entity

GS1

Risk category

AIMDD

Applicable legislation

AIMDD [Directive 90/385/EEC on active implantable medical devices]

Status

On the market

Quantity

1

Additional product description

The directSTIM lead is an implantable component of the directSTIM DBS System. The direcSTIM lead connects to the IPG through an extension. The directSTIM lead runs subcutaneously from the parietal bone up to the frontal area of the skull where it enters into the brain up to the target area.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• J020102DEEP BRAIN STIMULATION (DBS) LEADS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification