CROSSER®

Basic Information

• Brand Name: CROSSER®
• Primary DI: 10801741125567
• Version / Model: CRU14SA
• Catalog Number: CRU14SA
• Company Name: Bard Peripheral Vascular, Inc.
• Labeler DUNS: 135057938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-04-17
• Public Version Status: Update
• Public Device Record Key: 18fdaf56-0c7d-4f69-8c3a-b11cef601be8

Device Description

CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 146cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
45188	Mechanical atherectomy system catheter, coronary/peripheral	A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of both coronary and peripheral arteries (or vein grafts). It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801741125567	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	146	Centimeter