Disposable guide for 3D endocavity end-fire KDNG-XX

GUDID 03665134000011

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

KOELIS

Nonimplantable needle guide, single-use

• Primary Device ID: 03665134000011
• NIH Device Record Key: 79218aab-3004-4a3c-8afe-026186bd515b
• Commercial Distribution Discontinuation: 2022-04-08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable guide for 3D endocavity end-fire
• Version Model Number: KDNG00
• Catalog Number: KDNG-XX
• Company DUNS: 290318455
• Company Name: KOELIS
• Device Count: 24
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
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• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com
• Phone: +33458176811
• Email: QRA@koelis.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Special Storage Condition, Specify: Between 0 and 0 *do not compress
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665134000004 [Unit of Use]
GS1	03665134000011 [Primary]
GS1	03665134000028 [Package]; Package: carton [4 Units]; Discontinued: 2022-04-08; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180970

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-07-20

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• 03665134000851 - 3D Side Fire Endocavity Probe: 2024-08-07
• 03665134000936 - Steady Pro: 2024-06-11 Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ult
• 03665134000929 - MrDraw: 2023-10-10 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 Probe: 2023-04-13 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 Probe: 2023-04-13 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 Probe: 2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy