OT303V2I

Primary DI

08809294291512

Basic UDI-DI Code

B-08809294291512

Reference

DSPC-001

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

DalimsurgNET corporation

OCTOTM which is a detachable multi channel port can perform minimal invasive laparoscopic surgery which is called SILS(Single Incision Laparoscopic Surgery), or SPA(Single Port Access) Surgery The OCTOTMPort is a sterile, single patient use abdominal and pectoral access system comprised of two separately packaged components; - Port cap and Wound retractor The Port cap is a sterile, abdominal and pectoral access device consisting of plastic 5~12mm, 5mm ports, Gas valve, and Filter. The wound retractor is abdominal and pectoral access device consisting of the Upper frame, the Lower frame, and a Silicone retractor. The silicone retractor provides for circumferential wound retraction. The Bottom retractor ring is inserted into the abdomen or breast for device fixation. The Port cap is attached to the Wound retractor by aligning the port cap’s four connection notches with the Wound retractor’s four connection latches and snapping them together. The Gas valve and the Port seal allow the device to maintain gas pressure of peritoneal or breast while allowing the insertion of instruments to be inserted. The Wound retractors are available in three sizes, 30mm, 50mm and Long-type 50mm, to accommodate wide range of incision size. The Ports are available in two sizes, 5~12mm, 5mm to depend on number and size of using instruments. The smoke filtering system filters out hazardous surgical smoke and provides clear vision during the surgery.

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