Accessories Kit

Basic Information

• Brand Name: Accessories Kit
• Primary DI: M0975301770020
• Version / Model: 530177-002
• Catalog Number: 530177-002
• Company Name: BEST VASCULAR, INC.
• Labeler DUNS: 789032039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 10b6b6e0-ed00-4f95-a1fb-6b02d4aedcce

Device Description

Accessories Kit for the Novoste Beta-Cath System

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOU	Intravascular Radiation Delivery System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61708	Manual-afterloading brachytherapy system utility kit	A collection of non-sterile devices intended to be used with a manual-afterloading brachytherapy system to provide various additional functions including: fluid sampling for subsequent assessment of transferable radioactive contamination, dry/store components, facilitate locating and handling a radioactive source. It includes single-use items such as syringes, collection bags, Luer caps, adaptors/connectors, and/or reusable items such as system containers, flashlight, source recovery probe, magnifying glass, tweezers, appropriate to the functions it is intended to perform.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M0975301770020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000018	000