SmartPAN

Primary DI

07350108050135

Basic UDI-DI Code

B-07350108050135

Reference

960745

Device Types

Single use Sterile Sterilization

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Magle Chemoswed AB

SmartPAN Biochemical Leakage Indicator is a sterile hydrogel containing degradable starch microspheres loaded with bromothymol blue. It is provided as a single-use plastic applicator packaged in a blister pouch. SmartPAN comes ready-to-use and can be applied evenly to the surgical field. SmartPAN is intended to be used during every surgical intervention at the pancreas including minimally invasive surgery. SmartPAN enables the surgeon to localize pancreatic leakage, to evaluate quantity, and to perform refined closure. Visualization and targeted closure of leakage from pancreatic tissue can decrease occurrence of postoperative biochemical leakage which can lead to pancreatic fistula being one of the most important morbidity issues in pancreatic surgery.

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