LimFlow Stent Graft System

Dénomination commerciale

LimFlow Stent Graft System

Code d'IUD-ID

00850017630376

IUD-ID de base

0850017630SGXDDLLLCE21XB

Numéro de référence/catalogue

SGP-55100-CE-21

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

Stent Graft 5.5 x 100 mm with Pin & Pull mechanism

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 5.5 mm
• 100 mm

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P0704020299PERIPHERAL VASCULAR STENTS - OTHER

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

• CW999

  The use of the device should be limited to those specialists trained to perform the procedures for which this device is intended.
• 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 forsingle use only. Do not autoclave, reshape, re-sterilize or reuse. Exposure tohigh heat may cause changes to the functionality of the device. Reuse, even if re-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 receive anticoagulation 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