Disposable guide for 3D endocavity end-fire

Basic Information

• Brand Name: Disposable guide for 3D endocavity end-fire
• Primary DI: 03665134000011
• Version / Model: KDNG00
• Catalog Number: KDNG-XX
• Company Name: KOELIS
• Labeler DUNS: 290318455
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-07-20
• Public Version: 9
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 79218aab-3004-4a3c-8afe-026186bd515b
• Distribution End Date: 2022-04-08

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp 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 different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03665134000011	GS1
Unit of Use	03665134000004	GS1
Package	03665134000028	GS1	carton	4	Not in Commercial Distribution	2022-04-08

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180970	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: do not compress