Reusable guide

Basic Information

• Brand Name: Reusable guide
• Primary DI: 03665134000820
• Version / Model: GPK-490
• Company Name: KOELIS
• Labeler DUNS: 290318455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-24
• Public Version: 1
• Public Version Date: 2025-05-02
• Public Version Status: New
• Public Device Record Key: 24e8c10a-5f91-4416-a273-ed81562f9ace

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.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
60734	Needle guide, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	03665134000790	GS1
Primary	03665134000820	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141334	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Rigid container, padded. Store them in maximum hygienic conditions at room temperature