PV00025

Nom de l'organisation

i+Med S.Coop.

SRN

ES-MF-000008633

Statut du fabricant

Actif

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

• CW009

  Do not reuse, risk of infection
• CW001

  Do not re-sterilize. Re-sterilization can affect the physicochemical properties of the product and compromise its effectiveness and safety.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date.
• CW276

  Do not use with other products containing quaternary ammonium salts as benzalkonium chloride or with any surgical material treated with this type of substances because sodium hyaluronate can precipitate in their presence.
• CW036

  Do not administer BtHLINE in immediate association with laser or pulsed light treatments.
• CW135

  BtHLINE should not be administered to children. Keep out of children’s reach.
• CW161

  BtHLINE should not be administered to pregnant or breastfeeding women.
• CW999

  Do not administer BtHLINE to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer BtHLINE to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer BtHLINE to patients with coagulation defects and / or who are treated with anticoagulant medication. BtHLINE should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. BtHLINE should be administered exclusively by intradermal injection following a strict aseptic procedure. BtHLINE should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection. The syringe and the used needle should be discarded in a container provided for this purpose.
• CW010

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

Marché principal en Espagne ; disponible dans 11 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08437015992099

Basic UDI-DI

B-08437015992099

Numéro de référence/catalogue

PV00025

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 1 MU48

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

Santé des certificats sur le portefeuille de ce fabricant.