VISICOIL

Basic Information

• Brand Name: VISICOIL
• Primary DI: B887TLS110315170
• Version / Model: TLS-110-31517
• Catalog Number: TLS-110-31517
• Company Name: Izi Medical Products, LLC
• Labeler DUNS: 933506164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 5
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: ff3598c3-9e73-4868-b6b6-0660317f621b

Device Description

Qty2-1.10mmx0.5cm Gold VISICOILS 15mm Spacer 17g x 20cm Needle Stranded 2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.

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	B887TLS110315170	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120859	000