Thermablate EAS

Nom de l'organisation

Idoman Teoranta

SRN

IE-MF-000000090

Statut du fabricant

Actif

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

• CW030

  For use only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertions or dilation and curettage, are suitably trained (including Thermablate User Training), have adequate knowledge and familiarity with the Thermablate EAS system.
• CW007

  Product is supplied sterile in a foil vacuum bag
• CW009

  Single use device
• CW010

  For patient selection, contraindications for use of the device, detailed warnings and procedure information.
• CW133

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

Marché principal en Irlande ; disponible dans 16 pays au total.

Dénomination commerciale

Thermablate EAS

Code d'UDI-DI

05392000074118

Basic UDI-DI

B-05392000074118

Numéro de référence/catalogue

22001

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Supplied as Treatment Control Unit Kit Ref:22101. A hand-held, electrically-powered device designed to produce and regulate heat in a circulating fluid for ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is intended to be used with a disposable catheter component which circulates the heated fluid. It typically provides computerized control of treatment settings, including time, pressure, and temperature, and consists of an LCD user-interface to display treatment stage information and controls to initiate treatment.

URL des informations complémentaires

https://www.idoman-med.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12080201ENDOMETRIAL ABLATION EQUIPMENT

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• Date d'expiration
• Date de fabrication
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