Iriscope Biopsy Procedure Pack

Model / Reference

KITCAT-20-27-BS, KITCAT-16-19-B, KITCAT-15-19-PS, KITCAT-16-19-BS, KITCAT-16-19-B-X, KITCAT-20-27-B-X

Primary DI / UDI-DI

112040978310, 112040970216, 112040974825, 112040972569, 112078231208, 112081764831

Basic UDI-DI

PP10078IRIS.KITCAT33

EMDN Code

R07020102,Z12020885, R07020102,R07020301,Z12020885

Device Class

Class IIa

Medical Purpose

The procedure pack is intended to provide appropriate disposable devices necessary to take a biopsy sample in the lung tracts in combination with the video-endoscopic probe Iriscope, down to peripheral bronchi. The procedure pack must be used during an endoscopic intervention in combination with reusable devices intended to identify the biopsy site. The procedure pack must also be used in the operating channel of a bronchoscope. It includes one guide sheath, one syringe to flush, and one biopsy forceps.

EUDAMED SRN

BE-PR-000041516

• Iriscope EagleCath

  Class I

  CE/MDR

• GS1519P

  Class I

  CE/MDR

• T-Flush - Push-Pull Lock

  Class I

  CE/MDR

• GS1519PS

  Class I

  CE/MDR

• GS1619B

  Class I

  CE/MDR

• Iriscope Biopsy Procedure Pack

  Class IIa

  CE/MDR

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