FDA.reportPublic FDA data

Reusable guide

Primary DI
03665134000820
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
2025-04-24
Public version status
New
Distribution status
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
03665134000820PrimaryGS10
03665134000790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665134000820036651340008203665134000820
03665134000790036651340007903665134000790

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, reusableA non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Storage And Handling#

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

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
03665134000059Reusable guideGPK-4902020-07-17
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
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00841436125444CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125833Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436125857Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126045Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126656Multi-Purpose Workstation ™ StepperCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841436126663CradleCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-23
00841517112011iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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