TurboHawk™ Plus

GUDID 00763000402358

ATHERECTOMY THP-LX TH PLUS 7F EXT TIP US

MEDTRONIC, INC.

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• Primary Device ID: 00763000402358
• NIH Device Record Key: 186df8b6-777c-4293-9a4b-5a2f54c70ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboHawk™ Plus
• Version Model Number: THP-LX
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 7 French
• Length: 104 Centimeter
• Balloon Diameter: 2.6 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000402358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212027

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: 2021-10-04
• Device Publish Date: 2021-09-26

On-Brand Devices [TurboHawk™ Plus]

• 00763000402419: ATHERECTOMY THP-S TH PLUS 6F US
• 00763000402396: ATHERECTOMY THP-M TH PLUS 6F US
• 00763000402372: ATHERECTOMY THP-LS TH PLUS 7F STD TIP US
• 00763000402358: ATHERECTOMY THP-LX TH PLUS 7F EXT TIP US