G-NBOC2-35

Organization name

GEM SRL

SRN

IT-MF-000012892

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

4 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.
• CW999

  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.

Primary placement in Italy; available across 30 countries total.

Trade name

not provided

UDI-DI code

08031902000210

Basic UDI-DI

803190229Z

Reference / catalog number

G-NBOC2-35

Issuing entity

GS1

Risk category

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

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

• H90010102SYNTHETIC GLUES