Carthyal chondro

Dénomination commerciale

Carthyal chondro

05944728011885

B-05944728011885

Numéro de référence/catalogue

Carthyal chondro

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. Consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate produced from bovine cartilage. 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

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

• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• CONTRAINDICATIONS: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate or to any components • 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 may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. Should not be used in patients with known hypersensitivity to derived bovine material.

  AUTRE

• 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.

  AUTRE

• Should be administered in the synovial joint space only by medical professionals trained in intra-articular administration technique.

  AUTRE