Non-implantable, needle guide, reusable

Basic Information

• Brand Name: Non-implantable, needle guide, reusable
• Primary DI: 05704916001568
• Version / Model: UA1327
• Company Name: Bk Medical ApS
• Labeler DUNS: 310093901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-19
• Public Version: 5
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 221c02ac-ae36-4421-afe7-850c17bc2b02

Device Description

Reusable Endfire Biopsy Guide

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Chlorine Dioxide", "Hydrogen Peroxide", "Peracetic Acid"]

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
Primary	05704916001568	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173569	000
K223830	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: -25 – 70 Degrees Celsius