FDA.reportPublic FDA data

Disposable guide for 3D endocavity end-fire

Primary DI
03665134000011
Brand
Disposable guide for 3D endocavity end-fire
Company
KOELIS
Model
KDNG00
Device description
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
Published
2018-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K180970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180970000Disposable guides KDNG00Koelis2018-07-10ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665134000028PackageGS14In Commercial Distribution
03665134000011PrimaryGS10
03665134000004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665134000028036651340000283665134000028
03665134000011036651340000113665134000011
03665134000004036651340000043665134000004

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00do not compress
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
290318455
Device count
24
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665134000820Reusable guideGPK-4902025-04-24
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

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00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
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