Cera
Basic Information
- Primary DI
- 08720214005272
- Basic UDI-DI Code
- B-08720214005272
- Reference
- LE-PLUG-12
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- LifeTech Scientific (Europe) B.V.
Additional Description
The Cera Vascular Plug system is composed of Cera Vascular Plug and Introducer Kit. The Cera Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device. The plug is secured on both ends with a stainless steel sleeve. One micro stainless steel screw (nut) is welded to one end of the plug. A 1400mm Delivery Cable connecting the plug with a micro stainless steel screw is used to advance or retrieve the plug. PTFE membranes, designed to help seal the hole and to obstruct blood after Plug placement, are sewn into the plug. All metallic structures coating with titanium nitride (TiN), could improve its biocompatibility. The plug has various sizes ranging from 4 to 24mm in 2 millimeter increments.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C0104020103 | VASCULAR OCCLUSION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2166785CE03&2166785DE09 | DEKRA Certification B.V. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).