Lithobox
Basic Information
- Primary DI
- D-86800509202003N
- Basic UDI-DI Code
- B-86800509202003N
- Reference
- IMPL-700
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
Additional Description
Recurrent urinary stone disease is one of the oldest known diseases in the history of mankind with bad consequences up to kidney loss. Kidney stone crushing surgeries work on the principle that the electropneumatic ballistic energy applied by the bullet hitting the titanium probe moving with compressed air transfers the force on the kidney stone to the stone and disintegrates it. After the location of the stone is determined with endoscopy systems, the probe is passed through the endoscopy systems and brought into contact with the stone. When the probe touches the stone, the foot pedal is pressed and the shot is fired. It sends the collision energy to the stone with the compressed air created by the bullet in the handpiece and shatters the stone.
CND Nomenclature Codes
| Code | Description |
|---|---|
| G030502 | LITHOTRIPSY DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex IV | 1984-MDD-20-657 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).