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Nom de l'organisation

i+Med S.Coop.

SRN

ES-MF-000008633

Statut du fabricant

Actif

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

• CW011

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

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  SINGLE USE PRODUCT. The reuse of the product may lead to an infection since sterility is compromised after first use.
• CW001

  DO NOT RE-STERILISE, since re-sterilization may affect the physico-chemical properties of the product and compromise its efficacy and security.
• CW007

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

  The product should not be used after its expiration date.
• CW135

  KEEP OUT OF THE REACH OF CHILDREN.
• CW276

  Do not use with other products containing quaternary ammonium salts because sodium hyaluronate can precipitate in their presence.
• CW999

  Do not overfill the eye structures with the product, since it can cause increase in IOP or cause ocular damage. The quantity injected into the anterior chamber of the eye must be adjusted according to the volume of the aqueous humour and the anatomical structure to be protected. Monitor IOP increment especially during immediate postoperative period or in patients with pre-existing glaucoma. If significant rises are observed after surgery, appropriate treatment should be prescribed. To avoid increase of IOP, the product must be removed by irrigation and/oraspiration from the anterior chamber after surgery. Use only if the solution is clear. The product should be used with the provided cannula. The cannula and the syringe are for single intraocular use only and must be disposed after using the necessary precautions. Verify that the cannula is properly locked to the Luer-lock adaptor. Care should be taken to avoid trapping air bubbles behind the OVD. The normal precautions associated with ocular microsurgery should be observed. STRICT ASEPTIC PROCEDURE SHOULD BE FOLLOWED.

Marché principal en Espagne ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08437015992761

Basic UDI-DI

B-08437015992761

Numéro de référence/catalogue

-

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

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

• 1.2 MU48

• 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.

• Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES

Santé des certificats sur le portefeuille de ce fabricant.