NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2

Primary DI

D-G2-NBT43

Basic UDI-DI Code

B-G2-NBT43

Reference

G2-NBT

Device Types

Single use Sterile Sterilization

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

GEM SRL

The system permits application of Glubran 2 Surgical Glue as a spray in surgical laparotomy, laparoscopy and thoracoscopy procedures. For applications of Glubran 2 Surgical Glue see Intended Use of its Technical Card. The system consists of: - A steel canister placed in two half-shells in polycarbonate . The canister is filled with non-toxic, non-flammable HFC134/a (1,1,1,2 tetrafluoroethane) gas, used as the Glubran 2 Surgical Glue propellant. - A small tube equipped with a stopcock for passage of gas (figure/point 3) comes out from the canister valve through the upper half-shell. - The holder for the syringe , where the Glubran 2 Surgical Glue is withdrawn, is on the upper half-shell. - A flexible catheter, blue colored, 33 cm long, with an external diameter Ø of 5mm . There are two small tubes inside the catheter: one for passage of gas and one for passage of Glubran 2 Surgical Glue. Gas and Glubran 2 flow together in a spray tip which is placed inside the catheter at its distal end and that atomizes the glue. - A hub, at the proximal end of the catheter , connects to the small tube for gas and, with a female luer lock, to the syringe where the Glubran 2 Surgical Glue was withdrawn. - Two blunt point needles and two syringes , intended for withdrawing the Glubran 2 Surgical Glue from the single-dose vials, separately provided.

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