PS001.1.1

Nom de l'organisation

Jointherapeutics srl

SRN

IT-MF-000028991

Statut du fabricant

Inactif

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW267

  Chitosan
• CW009

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

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

  EUDAMED n'a pas publié de description pour ce code.
• CW129

  Local or systemic allergic reactions may occur, mainly in patients who are hypersensitive to one or more of the ingredients in the device. Signs and symptoms of an allergic reaction, such as skin rash, itching or hives, however, are considered to be rare. Main ingredient: 1 ml of solution contains 12.5 mg of sodium hyaluronate (1.25 %). Other ingredients: sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, potassium chloride, water for solution for injection and Chitlac®.
• CW083

  Local or systemic allergic reactions may occur, mainly in patients who are hypersensitive to one or more of the ingredients in the device. Signs and symptoms of an allergic reaction, such as skin rash, itching or hives, however, are considered to be rare. Main ingredient: 1 ml of solution contains 12.5 mg of sodium hyaluronate (1.25 %). Other ingredients: sodium chloride, dibasic sodium phosphate, monobasic sodium phosphate, potassium chloride, water for solution for injection and Chitlac®.
• CW136

  EUDAMED n'a pas publié de description pour ce code.
• CW036

  Do not use the product in combination with disinfectants containing quaternary ammonium salts (such as benzalkonium chloride) as hyaluronic acid is known to precipitate in the presence of this. No interactions with other local or locoregional anaesthetics.
• CW030

  • INGENERA® bio must be used at room temperature and only by qualified healthcare professionals. • Treat the injection site with a suitable antiseptic solution. • Observe all regulations regarding asepsis and infiltration techniques; • INGENERA® bio is designed for injections in the surface dermis or at the dermo-epidermal junction. • Use the most appropriate administration technique (for example, the linear or micro-papular technique). For the treatment of extensive areas, the linear threading or cross-hatching technique is recommended. • After administration, gently massage the area to further spread the product. • It is advisable to provide customised courses of treatment according to the needs of the patient.

Marché principal en Italie ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

80569925800080

Basic UDI-DI

B-80569925800080

Numéro de référence/catalogue

PS001.1.1

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

2 mL Cardboard box containing one pre-filled and graduated glass syringe, sterilized by moist heat, with Luer Lock adapter, in thermoformed blister, back-stop, two disposable needles 30G 1/2 "ETO sterilized (CE0123), one package leaflet, two / three adhesive traceability labels.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• 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.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Ce dispositif n'est actuellement lié à aucun autre dispositif.