ARTRO-PATCH

Dénomination commerciale

ARTRO-PATCH

D-000034545ARTROPATC2VBBG

B-000034545ARTROPATC2VBBG

Numéro de référence/catalogue

2VB

EUDAMED

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Injectable implant based on stabilized hyaluronic acid ARTRO-PATCH in a prefilled syringe

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

• Ne pas restériliser
• Ne pas réutiliser

  Use with caution in patients with venous or lymphatic stasis of extremities.

• Extreme caution is recommended when administering the medical device in the area of anatomical projection of nerves and their plexus. Violation of the implant injection technique in these areas may lead to traumatic damage of the peripheral nerves, increased pain, impaired sensitivity and development of paralysis in the corresponding areas of innervation. • Avoid injection of the medical device into tenosynovial muscle membranes, located near the injection site, which may cause the increase of the pain syndrome, movement disorders in the affected joint and adjacent joints.

  AUTRE

• Use with caution in patients with a history of chondrocalcinosis, since the injection may lead to disease exacerbation.

  AUTRE

• Ne pas utiliser si l’emballage est endommagé

  Prior to application, verify the package integrity and check its shelf life on a label. Do not use the implant after the expiration date or if the package integrity is failed.