VISICOIL MR Twin Line

Basic Information

• Brand Name: VISICOIL MR Twin Line
• Primary DI: EIBAPTTL050110210
• Version / Model: PTTL-050-11021
• Catalog Number: PTTL-050-11021
• Company Name: Izi Medical Products, LLC
• Labeler DUNS: 933506164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-22
• Public Version: 5
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: 677597f6-87a0-49cd-b276-628e9c6a2c90

Device Description

2 - 0.50mm x 0.5cm VISICOIL MR separated by a 10mm spacer (Non-Stranded) loaded in an 21 gauge pre-waxed brachytherapy needle.

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: MR Conditional
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXK	Source, Brachytherapy, Radionuclide	Radiology	892.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EIBAPTTL050110210	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120859	000