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
• Unused leftover adhesive must be discarded. In rare cases, modest, temporary inflammatory reactions may occur after application. The exothermic reaction that occurs during polymerisation, although contained within 50 °C, may sometimes cause a slight sensation of heat in some particularly sensitive patients (e.g. children or the elderly) at the point of application of the adhesive. The product is not recommended for use to secure 100% silicone catheters.

  OTHER

Primary placement in Italy; available across 30 countries total.

Trade name

GLUBRAN TISS 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.

08031902000210

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.

803190229Z

Reference / catalog number

G-NBOC2-35

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

Glubran® Tiss 2 skin adhesive is a class IIa surgical medical device that complies with current European regulations. Glubran® Tiss 2 is a second-generation, two-component adhesive for skin use, supplied with a single-use applicator tip packaged in a blister. It is ready-to-use, sterile, cyanoacrylate-based. It is a straw-coloured liquid that quickly polymerises on contact with tissues, creating a thin, impermeable, elastic film with high tensile strength, which ensures solid adhesion to tissues. The fluidity of the product and the characteristics of the applicator allow a controlled release of the adhesive even in areas that are difficult to treat. Once polymerized (60-90 sec.) it no longer has any adhesive power. The adhesive after polymerisation provides an effective antimicrobial barrier against the bacteria responsible for the most common infections. The product is compatible with most catheters used for central and peripheral venous access (CVC, PICC and Midline). It is available in packages of 0.25 ml, 0.35 ml, 0.5 ml containing 10 blisters with sterile single-dose vial and applicator tip.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.35 MU03

1 packaging level registered — each level carries its own UDI-DI.

• 08031902000210× 1 unitBase unit
  • 08031902000128× 10 units

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

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

• H90010102SYNTHETIC GLUES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.