TurboHawkTM

GUDID 00821684065747

ATHERECTOMY TH-LS-M TURBOHAWK ATK V06

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684065747
• NIH Device Record Key: 60c9c93e-3404-4929-a13f-96c20b6ff232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboHawkTM
• Version Model Number: TH-LS-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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684065747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093301

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

[00821684065747]

Ethylene Oxide

[00821684065747]

Ethylene Oxide

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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