Diamondback Coronary

Basic Information

• Brand Name: Diamondback Coronary
• Primary DI: 10850026568100
• Version / Model: DBEC-125
• Catalog Number: 7-10060-10
• Company Name: Cardiovascular Systems, Inc.
• Labeler DUNS: 024954518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-07
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 1957a7fa-779c-4e4b-a983-c2c9ad0252ce

Device Description

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT

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: 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: 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
MCX	Catheter, Coronary, Atherectomy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61205	Mechanical atherectomy system, coronary, line-powered	An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850026568100	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Crown diameter, 1.25mm
Device Size Text, specify			Nose Length, 5mm
Device Size Text, specify			Shaft Length, 135cm
Device Size Text, specify			Guidewire Size OD, 0.012 inches
Device Size Text, specify			Low Speed, 80 krpm
Device Size Text, specify			Medium Speed, krpm
Device Size Text, specify			High Speed, 120 krpm
Device Size Text, specify			Crown Type, Classic
Device Size Text, specify			Max OD, 0.0495
Device Size Text, specify			Intro Sheath, 6