transP - Reusable Guid Perine Grid 14G

GUDID 03665134000127

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."

KOELIS

Needle guide, reusable
Primary Device ID03665134000127
NIH Device Record Keye4525c19-dce9-416c-8c38-eaaf2573781b
Commercial Distribution StatusIn Commercial Distribution
Brand NametransP - Reusable Guid Perine Grid 14G
Version Model NumberKRNG.EL1.14-5
Company DUNS290318455
Company NameKOELIS
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com
Phone+33458176811
Emailqra@koelis.com

Device Dimensions

Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter
Guidewire Diameter1.02 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103665134000127 [Unit of Use]
GS103665134000219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

[03665134000127]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-04-25
Device Publish Date2020-07-17

Devices Manufactured by KOELIS

03665134000127 - transP - Reusable Guid Perine Grid 14G2025-04-25PERINE 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."
03665134000127 - transP - Reusable Guid Perine Grid 14G2025-04-25 PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides gu
03665134000790 - Reusable guide2025-03-18 The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument
03665134000851 - 3D Side Fire Endocavity Probe2024-08-07
03665134000936 - Steady Pro2024-06-11 Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ult
03665134000929 - MrDraw2023-10-10 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest
03665134000509 - 3D End-Fire Endocavity Probe2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
03665134000516 - 3D Side-Fire Endocavity Probe2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
03665134000523 - 2D Abdominal Probe2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
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