G-NBOC2-25

Nom de l'organisation

GEM SRL

SRN

IT-MF-000012892

Statut du fabricant

Actif

4 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  EUDAMED n'a pas publié de description pour ce code.
• CW001

  EUDAMED n'a pas publié de description pour ce 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.

Marché principal en Italie ; disponible dans 30 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08031902000227

Basic UDI-DI

803190229Z

Numéro de référence/catalogue

G-NBOC2-25

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 0.25 MU03

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• H90010102SYNTHETIC GLUES

Santé des certificats sur le portefeuille de ce fabricant.