HawkOne

Basic Information

• Brand Name: HawkOne
• Primary DI: 00821684057964
• Version / Model: H1-14550
• Company Name: Covidien LP
• Labeler DUNS: 968903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 5
• Public Version Date: 2021-07-14
• Public Version Status: Update
• Public Device Record Key: 1512e11f-9dd8-4589-a8ec-fd3936899226

Device Description

Cutter Driver

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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	00821684057964	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141801	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 28 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit