TurboHawk™

GUDID 00643169968400

ATHERECTOMY THS-LX-C TURBOHAWK ATK HEC U

MEDTRONIC, INC.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00643169968400
• NIH Device Record Key: 7ed8c739-0972-479f-8b92-ccdf7cc2bfa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboHawk™
• Version Model Number: THS-LX-C
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169968400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170191

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: 2018-08-16
• Device Publish Date: 2018-07-16

On-Brand Devices [TurboHawk™]

• 00643169968424: ATHERECTOMY TH-LX-M TURBOHAWK ATK SC UNI
• 00643169968400: ATHERECTOMY THS-LX-C TURBOHAWK ATK HEC U
• 00763000918958: ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC O
• 00763000918941: ATHERECTOMY THS-SS-CL TURBOHAWK BTK HECO
• 00763000918934: ATHERECTOMY TH-LX-M TURBOHAWK ATK SC UNI