Eu Mdr Eu Md Class 2a On The Market

Iriscope Biopsy Procedure Pack

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.

Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
111988661550
Basic UDI-DI Code
PP10078IRIS.KITCAT33
Reference
KITCAT-20-27-B
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Procedure pack including a biopsy forceps, guide sheath and syringe for pulmonary use.

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.

CND Nomenclature Codes

Code Description
Z12020885 PULMONARY ENDOSCOPIC INSTRUMENTS - CONSUMABLES

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The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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