TurboHawk™

GUDID 00821684065839

ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684065839
• NIH Device Record Key: 030f166f-c705-4f84-be39-d61f3dcef0a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboHawk™
• Version Model Number: THS-SS-CL
• 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

Device Dimensions

• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684065839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103618

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-23
• Device Publish Date: 2018-06-22

On-Brand Devices [TurboHawk™]

• 00643169968226: ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC U
• 00643169968202: ATHERECTOMY THS-SS-CL TURBOHAWK BTK HECU
• 00821684074008: ATHERECTOMY THS-LX-C TURBOHAWK ATK V08
• 00821684065853: ATHERECTOMY THS-SX-C TURBOHAWK BTK V03
• 00821684065839: ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03
• 00821684065815: ATHERECTOMY THS-SS-C TURBOHAWK BTK V03
• 00821684065785: ATHERECTOMY THS-LS-C TURBOHAWK ATK V08
• 00821684065754: ATHERECTOMY TH-LX-M TURBOHAWK ATK V06