CA804220

Nom de l'organisation

ProstaLund AB

SRN

SE-MF-000004428

Statut du fabricant

Actif

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• CW010

  There is a risk for complications if the CoreTherm® Catheter is not handled carefully and correctly. The risk for complications can be minimized by using the product as described in this instruction for use
• CW999

  Exercise care when inserting the CoreTherm® Catheter into the patient’s urethra, otherwise perforation and subsequent infection of the urethra may result. If the CoreTherm® Catheter is incorrectly placed or moves during treatment, or if the Microwave Antenna comes loose, the patient’s external sphincter may overheat, causing temporary or chronic incontinence.
• CW009

  The CoreTherm® Catheter is intended for single use only, otherwise cross-patient urinary infection could result. Each CoreTherm® Catheter has a unique catheter serial number (SN), and the software includes a lock which prevents reuse of a catheter. Do not attempt to use a CoreTherm® Catheter for more than one treatment session.
• CW999

  Please make sure to check the balloon with 20 ml of air before inserting it into the patient. While inside the patient’s bladder, inject 20 ml of sterile water slowly in order to prevent rupture of the balloon. Balloon rupture could lead to sliding of the catheter downwards and cause damage on the external sphincter and the urethra
• CW999

  Do not use saline solution when filling the balloon and water reservoir as this may result in increased temperatures due to interaction between the microwaves and the ions

Marché principal en Suède ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07350081910051

Basic UDI-DI

0735008191CA804X20Q8

Numéro de référence/catalogue

CA804220

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Treatment Catheter for thermotherapy treatment of BPE Duration of use: < 30min Material: Schelin Catheter

URL des informations complémentaires

https://coretherm.com/

Dimensions cliniques

• Standard

• 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.

• Z12160301EQUIPMENT FOR MICROWAVE PROSTATE THERMOTHERAPY