Innea Evidence

Dénomination commerciale

Innea Evidence

08051040330611

B-08051040330611

Numéro de référence/catalogue

INN62

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Main ingredient: sodium hyaluronate high molecular weight 20 mg/mL (40 mg/2 mL). Is indicated: - in the physiological aging process of the skin, the effects of which include the thickening of the stratum corneum (roughness and reduced brightness of the skin) and alterations of the elastic fibers of the dermis (wrinkles), - in dermal tissue repair process, in cases of scar results following superficial cutaneous trauma (e.g. acne scars and chicken pox).

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

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

• Consulter la notice d’utilisation
• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Is only indicated for intra-dermal injections and must only be dispensed by a doctor who has received specific training on the intra-dermal injection technique. Sensitive skin may be pretreated using a local anesthetic patch or cream. Please note that any anesthesia may cause redness or local hypersensitivity. There are no available clinical data (efficiency, tolerance) about injecting Innea Evidence into an area which has already been treated with another filling product. Patients should be advised not to apply any make-up for 12 hours after the injection and to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection. If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle. Do not inject into blood vessels. Do not use it in bones, tendons, ligaments or muscles. Do not inject into naevi. Discard the syringe and remaining product after use. Do not use if packaging has been 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.