Recanalization System

Basic Information

• Brand Name: Recanalization System
• Primary DI: 00801741202438
• Version / Model: BDRECANSYSTEMR
• Catalog Number: BDRECANSYSTEMR
• Company Name: Bard Peripheral Vascular, Inc.
• Labeler DUNS: 135057938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-30
• Public Version: 1
• Public Version Date: 2022-04-07
• Public Version Status: New
• Public Device Record Key: acc3f638-c9ef-4880-9d29-e3a835c4f4d4

Device Description

Recanalization System, Refurbished

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
PDU	Catheter for crossing total occlusions	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33854	Mechanical atherectomy system generator, electrical output	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate a high frequency electrical current that is converted via a separate transducer, typically within a handpiece, into vibrational energy for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a foot-switch and may include an integrated suction/aspiration system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741202438	GS1

Customer Contacts

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