G2-NBT

Organization name

GEM SRL

SRN

IT-MF-000012892

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 27 countries total.

Trade name

not provided

UDI-DI code

D-G2-NBT43

Basic UDI-DI

B-G2-NBT43

Reference / catalog number

G2-NBT

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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 - The holder for the syringe , where the Glubran 2 Surgical Glue is withdrawn, is on the upper half-shell.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, connects to the small tube for gas and, with a female luer lock, to the syringe where the Glubran 2 Surgical Glue was withdrawn.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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)