1321-0201

Nom de l'organisation

BEBIG Medical GmbH

SRN

DE-MF-000012644

Statut du fabricant

Actif

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Contra-indication: For the Afterloading systems and accessories, Transfer Tubes and Connectors/Couplings: The manufacturer of the Afterloading systems and accessories and Transfer Tubes and Connectors/Couplings is not aware of any specific contraindications. The indication of when the use of brachytherapy is appropriate for a patient is solely subject to the respective specialist and his professional expertise and assessment. Identification of contraindications for HDR brachytherapy is not readily available in guidelines or publications since it is dependent on the physician's evaluation of the patient, and it is not connected to general clinical parameters. Several contraindications to HDR brachytherapy of prostate cancer are discussed in the document "The evolution of brachytherapy for prostate cancer" : •Ataxia telangiectasia •Pre-existing rectal fistula •Unacceptable operative risks or medicallyunsuitable for anesthesia •Distant metastases These contraindications do not necessarily apply to other HDR brachytherapy applications, for example, intraluminal HDR Brachytherapy, in which metastases are not contra-indicated (palliative care). Instead, the following contraindications are suggested : •Patients that have a medical contraindicationfor radical surgery •Risk of radiation injury to critical organs •Very large tumors where the prescribed dosecannot be achieved •Tracheal or bronchial involvement •Cervical esophagus location •Stenosis that cannot be bypassed Some contraindications to radical treatment using HDR Gynecologic Brachytherapy are given in an ABS task group proposal : •Prior pelvic radiotherapy with brachytherapy •Life expectancy < 6 months

Marché principal en Espagne ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04065983000023

Basic UDI-DI

40659830001BBY

Numéro de référence/catalogue

1321-0201

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z11010301BRACHYTHERAPY RADIATION SYSTEMS

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