LimFlow Stent Graft System

Nom de l'organisation

LimFlow SA

SRN

FR-MF-000011529

Statut du fabricant

Actif

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

• CW999

  The device should not be used without first reading and understanding these directions in their entirety.
• CW999

  The Stent Graft System is designed and intended for single use only. Do not autoclave, reshape, re-sterilize or reuse. Exposure to high heat may cause changes to the functionality of the device. Reuse, even ifre-sterilized, can compromise the Stent Graft System performance characteristics and may cause infection.
• CW999

  Do not use organic solvents (e.g. alcohol) with the delivery system.
• CW999

  Use in patients with concomitant hepatic insufficiency has not been evaluated.
• CW999

  Use in pregnant and breastfeeding women has not been evaluated.
• CW999

  Long-term outcomes in patients with renal insufficiency have not been evaluated.
• CW999

  Contraindicated in patients with deep venous thrombus in target vein.
• CW999

  Contraindicated in patients with uncorrected bleeding disorders or patients who cannot receivea nticoagulation or antiplatelet aggregation therapy.
• CW999

  Contraindicated in patients with a poor cardiac output, because an AV fistula may increase the risk for cardiac decompensation.
• CW999

  Contraindicated in neonate and pediatric patients.
• CW999

  MRI Conditional
• CW999

  The use of the device should be limited to those specialists trained to perform the procedures for which this device is intended.

Marché principal en France ; disponible dans 12 pays au total.

Dénomination commerciale

LimFlow Stent Graft System

Code d'UDI-DI

00850017630482

Basic UDI-DI

0850017630RGSDDLLLCE24RT

Numéro de référence/catalogue

RGS-35060-CE-24

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

3.5 mm Crossing Stent, Thumwheel delivery mechanism

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• Stent Diameter

• P0704020299PERIPHERAL VASCULAR STENTS - OTHER

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

Santé des certificats sur le portefeuille de ce fabricant.