TurboHawk™

GUDID 00821684065754

ATHERECTOMY TH-LX-M TURBOHAWK ATK V06

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684065754
• NIH Device Record Key: cd5383da-807a-4b59-91c2-dc79fbeac446
• Commercial Distribution Discontinuation: 2019-03-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TurboHawk™
• Version Model Number: TH-LX-M
• 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

• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter
• Length: 9 Centimeter

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	00821684065754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093301

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: 2
• Public Version Date: 2019-04-30
• Device Publish Date: 2018-07-07

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