Twin Transport Case

Basic Information

• Brand Name: Twin Transport Case
• Primary DI: M097TRC00020
• Version / Model: TRC-0002
• Catalog Number: TRC-0002
• 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: 05d2ef2b-e8f7-41e9-ada9-21c8d59259a1

Device Description

Twin Transport Case 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
61709	Manual-afterloading brachytherapy system source transfer device transport case/set	A non-sterile portable plastic container designed to store and transport a manual-afterloading brachytherapy system source transfer device. It includes accessory devices such as a flashlight, radioactive source recovery probe, magnifying glass, and tweezers intended to support the parent device. This device is intended to function solely as a transport/storage case; it does not shield radiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M097TRC00020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000018	000