Stealth

Basic Information

• Brand Name: Stealth
• Primary DI: 10850000491301
• Version / Model: RAD-SC30-125
• Catalog Number: 7-10059-05
• Company Name: Cardiovascular Systems, Inc.
• Labeler DUNS: 024954518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-10
• Public Version: 1
• Public Version Date: 2019-09-18
• Public Version Status: New
• Public Device Record Key: cc8d64bc-b137-4eb6-9ce7-810db8e81dbe

Device Description

STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm 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
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44307	Mechanical atherectomy system catheter, peripheral	A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850000491301	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Intro Sheath 5 Fr
Device Size Text, specify			Max OD 0.063 inches
Device Size Text, specify			Crown Type Solid
Device Size Text, specify			High Speed 120 krpm
Device Size Text, specify			Medium Speed 90 krpm
Device Size Text, specify			Low Speed 60 krpm
Device Size Text, specify			Guidewire 0.014 inches
Device Size Text, specify			Shaft Length 200 cm
Device Size Text, specify			Nose Length 10 mm
Device Size Text, specify			Crown Diameter 1.5 mm