Promovia Hydro Balance 50

Nom de l'organisation

SRN

IT-MF-000026730

Statut du fabricant

Actif

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

• CW009

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

  EUDAMED n'a pas publié de description pour ce code.
• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW007

  EUDAMED n'a pas publié de description pour ce code.
• CW032

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

  Is suitable only for intra-articular injections and must only be dispensed by a medical doctor who has received specific training on the intra-articular injections technique. The device must not be used in pregnant or breastfeeding women, as has not been tested in such cases. The device must be not be used in patients with ascertained individual hypersensitivity to any of the ingredients of the product. As no clinical experience is available for the use of Hyaluronan in children, treatment with Promovia Hydro Balance is not recommended in these cases. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days. After the intra-articular injection it is advisable to recommend to the patient to avoid driving for at least 48 hours. Is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Before use, check the integrity of the syringe and the expiration date. The product should not be injected in the presence of a infected or severely inflamed joint. The infiltration must be avoided in the case of infection in place or inflammatory conditions of the skin in proximity of the injection. Do not use the product if the package is already opened or damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. For additional information consult instruction for use

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

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Dispositifs médicaux de Classe III dans EUDAMED

Santé des certificats sur le portefeuille de ce fabricant.