Organization name

GEM SRL

SRN

IT-MF-000012892

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Use protective glasses during the procedure. In the event of accidental contact of Glubran® 2 Surgical Glue with the eyes, immediately flush with water. If the product has polymerized, it will detach spontaneously after about 2-3 days.The gas canister is a pressure vessel. It must be protected from sunlight, must not be exposed to temperatures above 30°C and must not be perforated or burnt even after use. Once activated, the canister must always be kept in a vertical position.The device can be used a maximum of two times during the same operation on the same patient. The device cannot be reconditioned or re-used or re-sterilised after it has been opened for the first time. Reuse poses a risk of infection to the patient due to loss of sterility of the contents. To aim Glubran® 2 correctly and safely, please read point 9 of the ‘Instructions for Use’ carefully.Before using the spray always check that the system is functioning correctly by performing a spray test on a surgical drape. To minimise the risk of unwanted obstruction of the spray device, keep the tip of the catheter approximately 2 cm away from the bleeding site. After using Glubran® 2, to avoid possible damage to the endoscope, the internal catheter should be retracted into the protective sheath before removing the spray device from the working channel. At the end of surgery, empty the gas canister completely before disposing of the spray device, leaving the red and blue stopcocks open to prevent any residual gas from interfering with the disposal procedurel.

  OTHER

Primary placement in Italy; available across 31 countries total.

Trade name

ENDONEB

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.

08031902000371

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.

80319023A3

Reference / catalog number

G2-NBT-ENDO

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.

GS1

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

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The ENDONEB class IIa medical device allows the application of Glubran® 2 Surgical Glue in spray form in digestive endoscopy procedures. It is suitable for use with both gastroscopes and colonoscopes with an working channel of not less than 2.6 mm.

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.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.