SmartPAN

Dénomination commerciale

SmartPAN

Code d'IUD-ID

073501080500C7X

IUD-ID de base

B-073501080500C7X

Numéro de référence/catalogue

96 07 45

Entité d'attribution

HIBCC

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

SmartPAN is a biodegradable indicator intended for visual detection of biochemical leakage after tissue closure during surgical intervention

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.

• G99GASTROINTESTINAL DEVICES - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  Cautions:: For the safe use of SmartPAN the preparation and administration have to be done by health care professionals experienced with pancreatic surgery.  Extensive usage of thermoelectric hemostatic devises may alter tissue color and thereby impair visualization of SmartPAN indication.  Application of SmartPAN needs to be conducted carefully to place an even product layer on the tissue surface of interest without relevant time-delay during application. Optimal product layer covers tissue surface completely and homogenously without local heterogeneous increase of layer-thickness.  Syringe-style applicator allows for standardized usage to assure precise and comparable indicator reaction. SmartPAN appears orange when applied, but locally turns green-bluish over pancreatic leakage. This indicator reaction happens immediately or within seconds. Color change only appears in close proximity to relevant pancreatic leakage.  SmartPAN should be used immediately after removal of the cap to avoid contamination of the product.  SmartPAN is packaged for single patient use only. Discard remaining opened material after each medical procedure.  Do not re-sterilize SmartPAN.  Do not place SmartPAN in a procedure pack/tray that will be sterilized prior to use. Exposure of SmartPAN, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam) will alter its viscosity and may render the product unusable.  Do not use more than one device per treatment

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.