Organization name

GEM SRL

SRN

IT-MF-000012892

Manufacturer status

Active

D-G2-NBT43

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

NEBULIZZATORE PER COLLA CHIRURGICA GLUBRAN 2

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-G2-NBT43

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-G2-NBT43

Reference / catalog number

G2-NBT

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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 - The holder for the syringe , where the Glubran 2 Surgical Glue is withdrawn, is on the upper half-shell.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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

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

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.