DRAINAGE CATHETER & SETS

Dénomination commerciale

DRAINAGE CATHETER & SETS

00812261016382

081226101DCS007LH

Numéro de référence/catalogue

U-DPD-10/30

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 Ultima Direct Puncture Drainage Set is used for percutaneous nephrostomy drainage following the Direct - Puncture technique, particularly when there is a dilated urine collection system or hydronephrosis., The catheter is back-loaded on a two-part trocar needle,straightened and then introduced directly through a skin incision, The procedure does away with the use of guidewire and fascial dilators, as dilatation is not required, The set may also be used for cyst and abscess drainage

URL des informations complémentaires

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

Dimensions cliniques

• 10 MU170
• 30 MU10

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

• U040201NEPHROSTOMY KITS, DIRECT PUNCTURE

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• 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
• Contraindication • Bleeding tendency • Hypertonia • Intake of anticoagulants

  AUTRE

• Warning/ Precaution: • Periodic evaluation of drainage catheter is recommended. • Do not force the catheter against any resistance without having previously determined its cause under fluoroscopy. • Fluoroscopic evaluation of placement is recommended. • 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. • Do not use if package is opened or damaged. • Dispose in accordance with recognized medical practice and under observance of applicable law and regulation. • Constant fluoroscopic guidance is required • Check compatibility of guidewire before use. • Only experienced surgeons should place this device • 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.