BIOPORT CROSSLINK

Nom de l'organisation

Rompharm Company SRL

SRN

RO-MF-000002517

Statut du fabricant

Actif

8 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.
• CW032

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  CONTRAINDICATIONS: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate or to any components of BIOPORT CROSSLINK • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding BIOPORT CROSSLINK may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. BIOPORT CROSSLINK should not be used in patients with known hypersensitivity to derived bovine material.
• CW999

  Injection site must be properly disinfected (70% alcohol or with another disinfectant). Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronic acid can precipitate in their presence.
• CW999

  BIOPORT CROSSLINK should be administered in the synovial joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  As no clinical evidence is available on the use of sodium hyaluronate and chondroitin sodium sulfate in patients with concomitant inflammatory arthropathy (such as rheumatoid arthritis, gouty arthritis), recent orthopedic surgery or trauma at the index joint, the treatment with BIOPORT CROSSLINK is not recommended in these patients.

Marché principal en Espagne ; disponible dans 6 pays au total.

Dénomination commerciale

BIOPORT CROSSLINK

Code d'UDI-DI

05944728008250

Basic UDI-DI

B-05944728008250

Numéro de référence/catalogue

BIOPORT CROSSLINK

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

BIOPORT CROSSLINK is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. BIOPORT CROSSLINK consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate produced from bovine cartilage. BIOPORT CROSSLINK is a sterile viscoelastic solution processed using an aseptic processing technique and supplied in a disposable glass syringe delivering 3 mL of solution.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 3 MU03

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES