Turbo-Power™ 420-050

GUDID 00813132024833

Turbo-Power™ Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: 00813132024833
• NIH Device Record Key: b4fb51be-4afe-407f-a43e-0e7595dce4a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Turbo-Power™
• Version Model Number: 420-050
• Catalog Number: 420-050
• Company DUNS: 151047370
• Company Name: Spectranetics Corporation
• 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: true
• 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: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com
• Phone: 1-800-633-0960
• Email: complaints@spnc.com

Device Dimensions

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132024833 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162561

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

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

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

[00813132024833]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-08

On-Brand Devices [Turbo-Power™]

• 00813132026783: Turbo-Power™ Laser Atherectomy Catheter
• 00813132026776: Turbo-Power™ Laser Atherectomy Catheter
• 00813132025397: Turbo-Power™ Laser Atherectomy Catheter
• 00813132025366: Turbo-Power™ Laser Atherectomy Catheter
• 00813132024833: Turbo-Power™ Laser Atherectomy Catheter
• 00813132022983: Turbo-Power™ Laser Atherectomy Catheter