PINECY® Kyphoplasty Balloon Catheter

Primary DI

06935456210427

Basic UDI-DI Code

69354562PLYL03XF

Reference

FA03001-17

Device Types

Single use Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Princeton Medical Scientific Co.,Ltd

"The working surface of the Kyphoplasty Balloon Catheter is designed to compress cancellous bone and/or move cortical bone as it inflates. The inflatable component of the Kyphoplasty Balloon Catheter is near the distal tip of the device. ①The shaft contains two non-communicating lumens. The outer lumen is used for Kyphoplasty balloon catheter inflation, and the central lumen contains a removable protective wire for Kyphoplasty balloon catheter insertion. ②The proximal end of the shaft has a Y connector. The inflation port of the Y connector is contiguous with outer lumen. The protective wire port is contiguous with the inner lumen and contains the protective wire. The protective wire has a screw cap at its proximal end , and the screw cap is stuck by the protection wire, and the whole can be removed from the product at will. ③There are two forms at the inflation port, one is without a check valve, and the other is with a check valve. ④Located at the distal end of the exit marker band is a string of numbers indicating the size of the balloon,such as 6.0x10,6.0x15,6.0x20,5.0x10,6.0x11. ⑤The exit marker band located on the outer lumen is used during kyphoplasty balloon catheter insertion. ⑥Markers located at the distal and proximal end of the deflated working surface allow fluoroscopic visualization of the deflated Kyphoplasty balloon catheter during positioning."

The Basic UDI-DI associated with this device has 14 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).