transP - Reusable Guid Perine Grid 18G

GUDID 03665134000110

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

Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable
Primary Device ID03665134000110
NIH Device Record Key7994a8f8-05e4-4d2f-9ec0-5c06a3c128fe
Commercial Distribution StatusIn Commercial Distribution
Brand NametransP - Reusable Guid Perine Grid 18G
Version Model NumberKRNG.EL1.18-5
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter
Guidewire Diameter1.63 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103665134000110 [Unit of Use]
GS103665134000226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


[03665134000110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

Devices Manufactured by KOELIS

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
03665134000530 - 2D Linear Probe2023-04-13 Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
03665134000189 - CON LEAD 14G2023-04-13 Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound pro
03665134000301 - LIN LEAD 18G2023-04-13 Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe.
03665134000318 - LIN LEAD 14G2023-04-13 Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe.

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