KOELIS

Address:22 Chemin du Vieux Chene,MEYLAN Isere,FR

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Device Description : The product concerned is a plastic guide designed to be plugged on an endocavity The product concerned is a plastic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. The guide is composed of 2 parts welded together to have:• a channel to receive and guide the linear instrument • a clip to allow the guide stability on the transducer • 2 pins for attachment in the notches of the probe• a guide cone to introduce easily the needle into the tube

Device Class :

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 24

- Catalog Number :

Device Description : A mobile workstation composed by a central unit with ultrasound beamformer, a A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart,Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.

Device Class :

Duns Number: 290318455

Premarket Exempt : No

Product Code : IYO, IYN, LLZ, ITX

Prescription Use : Yes

Device Count : 1

Device Description : The device concerned is a metallic guide designed to be plugged on an endocavity The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access. Sold *5

Device Class :

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : PERINE range guides are made up of one part fixed on the ultrasound probe, which PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices."

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : PERINE range guides are made up of one part fixed on the ultrasound probe, which PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : "PERINE range guides are made up of one part fixed on the ultrasound probe, whic "PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices."

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : PERINE range guides are made up of one part fixed on the ultrasound probe, which PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : The guides from PERINE range are intended to guide a needle during ultrasound-g The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention.PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : The guides from PERINE range are intended to guide a needle during ultrasound-g The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention.PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5

Device Description : PERINE range guides are made up of one part fixed on the ultrasound probe, which PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides guide needles of 14 to 20 gauges. The guiding aims to place the needle in the ultrasound image plane.The guides are reusable medical devices.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 5