koelis.comDisposable Guides KDNG00
Koelis
KOELIS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008487708 | 3008487708 | KOELIS | 1 | N | 2027-01-01 | 22 Chemin Du Vieux Chene MEYLAN Isere FR 38240 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03665134000011 | Disposable guide for 3D endocavity end-fire - 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 | +33458176811 | QRA@koelis.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 121945 | 1856794171 | K180970 | Disposable guides KDNG00 | ITX | 2018-07-10 |
| 121945 | 1666540913 | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | ITX | 2017-07-31 |
| 121945 | 1055603626 | K170521 | TRINITY/3D PROSTATE SUITE | IYN | 2017-05-30 |
| 121945 | 1776420050 | K160357 | TRINITY | IYN | 2016-05-02 |
| 121945 | 1539382977 | K141334 | REUSABLE GUIDE | ITX | 2014-07-11 |
| 121945 | 1421906873 | K131448 | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION | LLZ | 2013-07-26 |
| 121945 | 1977434053 | K100793 | UROSTATION 3D PROSTATE SUITE | LLZ | 2010-09-22 |
Product Codes Associated With Registrations#
PMN#
Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range
Koelis
TRINITY/3D PROSTATE SUITE
KOELIS
TRINITY
KOELIS
REUSABLE GUIDE
KOELIS
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
KOELIS
UROSTATION 3D PROSTATE SUITE
KOELIS
GUDID#
Steady Pro - Steady Pro Probe Holding Arm with I and U extension and rail clamping baseThe Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.
2022-10-06
Steady Pro - Probe holder for transrectal approach
2022-10-06
Steady Pro - Universal clamping baseThe steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.
2022-10-06
TRINITY - KURO-3000-3
2022-03-31
MR DRAW - A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy.
2020-07-23
transP - Reusable Guid Perine Grid 18G - 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.
2020-07-17
transP - Reusable Guid Perine Nail 14G - 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.
2020-07-17
transP - perine full grid 18G - 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.
2020-07-17
transP - perine full grid 14G - 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.
2020-07-17
transP - Perine Adaptater - 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.
2020-07-17
TRINITY - 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.
2019-11-08