Basic UDI-DI
Eu Mdr
Eu Md Class 3
Shockwave C2+ Coronary IVL Catheter, Procedure Pack
Code: 00195451C2KIVLXX
Devices
4
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- 00195451C2KIVLXX
- Issuing Agency
- GS1
- Device Model
- C2KIVL2512
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 3
- Last Updated
- September 16, 2022
Medical Purpose
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 4 devices.
| Name | Status |
|---|---|
| Shockwave C2+ Coronary IVL Catheter | On the market |
| Shockwave C2+ Coronary IVL Catheter | On the market |
| Shockwave C2+ Coronary IVL Catheter | On the market |
| Shockwave C2+ Coronary IVL Catheter | On the market |