HAXL ONE

Nom de l'organisation

i+Med S.Coop.

SRN

ES-MF-000008633

Statut du fabricant

Actif

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• CW010

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

  The product is for single use. No reuse; risk of infection
• CW001

  Do not re-sterilize, re-sterilization can affect the physico-chemical 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.
• CW135

  HAXLONE should not be administered to children.
• CW161

  HAXLONE should not be administered to pregnant or breastfeeding women.
• 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. In order to prevent any possible interaction, avoid joint administration with other intra-articular products. There is no known interaction with other local anesthetics.
• CW999

  Do not administer HAXL ONE to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer HAXL ONE to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer HAXL ONE to patients with coagulation defects and / or who are treated with anticoagulant medication.The use of HAXL ONE in any joint other than the knee and for other conditions has not been studied.HAXL ONE must be injected strictly into the intra-articular space following aseptic injection procedures.HAXL ONE should be administered with sterile Luer-lock needles. Do not inject into a blood vessel or surrounding tissues. To avoid pain after the injection, a recommendation should be given to keep the local site still after the injection.The syringe and the used needle should be discarded in a container provided for this purpose.

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

Dénomination commerciale

HAXL ONE

Code d'UDI-DI

08437015992747

Basic UDI-DI

B-08437015992747

Numéro de référence/catalogue

PV00035

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

• 4.4 MU03

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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