EasyCool 80G4 S

Organization name

MedFact Engineering GmbH

SRN

DE-MF-000010098

Manufacturer status

Active

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

• CW999

  The catheter should only be introduced by using x-rays. Afterwards the device can be controlled using X-ray or electronavigational systems.
• CW011

  Before use, the compatibility to other used systems has to be tested and ensured by the user!
• CW007

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW029

  Before use check the catheter for mechanical outside integrity like rough surface, sharp edges, etc.

Primary placement in Germany; available across 14 countries total.

Trade name

EasyCool 80G4 S

UDI-DI code

04255650100655

Basic UDI-DI

B-04255650100655

Reference / catalog number

105-418

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Irrigated, manual deflectable Mapping- and Ablation-Catheter

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Length of tip electrode — 4 MU50
• Length of deflectable tip — 80 MU50

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C020301ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS