TurboHawk THS-LX-C

GUDID 00821684047200

Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC Technology

Covidien LP

Mechanical atherectomy system catheter, peripheral Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684047200
• NIH Device Record Key: d51829e4-2605-4c46-8819-0ef1ba6373cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboHawk
• Version Model Number: THS-LX-C
• Catalog Number: THS-LX-C
• 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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684047200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111723

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-12

On-Brand Devices [TurboHawk]

• 00821684047941: Peripheral Plaque Excision System;Small Vessel Standard Tip
• 00821684047934: Peripheral Plaque Excision System;Small Vessel Standard Tip
• 00821684047927: Peripheral Plaque Excision System;Small Vessel Extended Tip
• 00821684047217: Peripheral Plaque Excision System;Large Vessel Standard Tip
• 00821684047200: Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC Technology
• 00821684047156: Peripheral Plaque Excision System;Large Vessel Standard Tip with MEC TechNlogy
• 00821684047149: Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC TechNlogy