HawkOneTM

GUDID 00821684073551

ATHERECTOMY H1-14550 CUTTERDRIVER V02

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684073551
• NIH Device Record Key: 21c77e26-320c-4615-a44a-bc79d200fbd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HawkOneTM
• Version Model Number: H1-14550
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -29 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684073551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141801

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00821684073551]

Radiation Sterilization

[00821684073551]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

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