Thermablate EAS

Organization name

Idoman Teoranta

SRN

IE-MF-000000090

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• 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 and detailed warnings.
• CW133

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.

Primary placement in Ireland; available across 17 countries total.

Trade name

Thermablate EAS

UDI-DI code

05392000074101

Basic UDI-DI

B-05392000074101

Reference / catalog number

21004

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

A device in the form of a thin tube with an inflatable balloon at its distal tip intended to be used to provide heat 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 designed to be attached to a hand-held control unit in which a fluid medium (e.g., glycerin) is heated before being forced into the catheter balloon under pressure to compress against the uterine wall and circulate within for homogenous heat distribution. This is a single-use device.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• U080101CATHETERS FOR ENDOMETRIAL ABLATION

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification