FDA.reportPublic FDA data

Reusable guide

Primary DI
03665134000059
Brand
Reusable guide
Company
KOELIS
Model
GPK-490
Device description
The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument through transrectal access.
Published
2020-07-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141334000REUSABLE GUIDEKoelis2014-07-11ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665134000059PrimaryGS10
03665134000042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665134000059036651340000593665134000059
03665134000042036651340000423665134000042

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length161.5Millimeter
Width40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Rigid container, padded. Store them in maximum hygienic conditions at room temperature
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33458176811qra@koelis.com

Regulatory Flags#

DUNS number
290318455
Device count
5
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665134000011Disposable guide for 3D endocavity end-fireKDNG002018-07-20
03665134000820Reusable guideGPK-4902025-04-24
03665134000165NAIL rangeNAIL.142023-04-04
03665134000158NAIL rangeNAIL.182023-04-04
03665134000219transP - Reusable Guid Perine Grid 14GKRNG.EL1.142020-07-17
03665134000226transP - Reusable Guid Perine Grid 18GKRNG.EL1.182020-07-17
03665134000233transP - Reusable Guid Perine Nail 18GKRNG.EL2.182020-07-17
03665134000240transP - Reusable Guid Perine Nail 14GKRNG.EL2.142020-07-17
03665134000257transP - perine full grid 18GKRNG.EL4.182020-07-17
03665134000264transP - perine full grid 14GKRNG.EL4.142020-07-17
03665134000776Steady ProKSP.SUPP.TR2022-10-06
03665134000912Steady ProKSP.SUPP.TP22024-06-03
03665134000745Steady ProKSP.SUPP.TP2022-10-06
03665134000271transP - Perine Adaptater KRGA.EL52020-07-17
03665134000288CON LEAD 18GKRNG.AB.182023-04-05
03665134000295CON LEAD 14GKRNG.AB.142023-04-05
03665134000127transP - Reusable Guid Perine Grid 14GKRNG.EL1.14-52020-07-17
03665134000301LIN LEAD 18GKRNG.LN.182023-04-05
03665134000318LIN LEAD 14GKRNG.LN.142023-04-05
03665134000035TRINITYKURO3000-22019-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
10841436122662Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2025-12-31
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07