EGIS Biliary M-Valve Stent

Nom de l'organisation

VASNOVA INC.

SRN

KR-MF-000015781

Statut du fabricant

Actif

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

• CW026

  The patients who have implanted this device may be scanned safely on a MRI Environment that satisfies as below: • Static magnetic Field of 1.5-Tesla and 3.0-Tesla • Maximum spatial gradient magnetic field of 3,000 gauss/cm • Maximum MR system reported, whole body averaged specific absorption rate(SAR) of 2 w/kg Additional description . Under the above defined scanning conditions, the maximum temperature rise is expected to be less than 2.8℃ when the EGIS Biliary stent was MRI performed for 15 minutes of scanning. From the non-clinical testing, the distorted image due to the medical device was extended up to 2.5 mm when it was scanned under T1 SE, GRE pulse sequence of 3.0-Tesla MRI.
• CW010

  Contraindications for the EGIS Biliary Stents include, but may not be limited to: Patients with angina or coagulopathy or uncorrected bleeding disorders, Strictures that do not allow passage of a guidewire, Patients with large-volume ascites, Extensive hepatic metastases precluding a percutaneous transhepatic approach, Neonatal, pediatric and adolescent use, Benign strictures – except for removable configurations, Any use other than those specifically outlined under indications for use, Patients with contraindicated endoscopic procedure

Marché principal en Tchéquie ; disponible dans 7 pays au total.

• 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.

• P0502BILIARY AND PANCREATIC PROSTHESES

• Dispositifs médicaux de Classe IIb dans EUDAMED

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