ARMADA Dilators & Sets

Dénomination commerciale

ARMADA Dilators & Sets

00812261012735

081226101DST010RV

Numéro de référence/catalogue

FD6

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Fascial Dilators are used for dilatation of the percutaneous tract over the guidewire., Radiopaque tubing made up of polyethylene material to maximize patient comfort, Female luer lock allows heparin, contrast media and other solutions to be injected using standard luer lock syringe, Uniform taper minimizes trauma to patient, Smooth surface assists in easier introduction of guidewire, Integrally molded hub.

URL des informations complémentaires

https://www.allwinmedical.com/e-ifu/

Dimensions cliniques

• 6 MU170
• 20 MU10

1 niveau de conditionnement enregistré — chaque niveau porte son propre IUD-ID.

• 00812261012735× 1 unitéUnité de base
  • 10812261012732× 5 unités

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

• U03010199PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER

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

• Avertissement

  Federal (USA) law restricts this device to sale by or on the order of a physician.

• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Warning/ Precaution: • Do not use if package is opened or damaged. • Dispose in accordance with recognized medical practice and under observance of applicable law and regulation. For single use only. • Attempt to resterilize a single use device may compromise its structural integrity and/or lead to device failure which may result in patient injury or illness. • Storage temperature between 5ºC to 30ºC. • In case of in serious incident shall be reported to user and competent authority in the member state. • Do not reuse, reprocess & resterilize: Reuse, Reprocessing & Resterilization may compromise the structural integrity, can also create risk of contamination & may not give desired result or create complications, infections which may result in injury, illness or death.