Turbo-Elite™ 423-001

GUDID M2044230010

Turbo-Elite™ Laser Atherectomy Catheter

Spectranetics Corporation

Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: M2044230010
• NIH Device Record Key: feca3737-0f66-4322-94f5-e82a4e594b5b
• Commercial Distribution Discontinuation: 2019-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Turbo-Elite™
• Version Model Number: 423-001
• Catalog Number: 423-001
• 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

Device Dimensions

• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M2044230010 [Primary]

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

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

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

[M2044230010]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-26
• Device Publish Date: 2014-08-27

On-Brand Devices [Turbo-Elite™]

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• M204423001AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204420159AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204420006AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204417156AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204417152AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204414159AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204414151AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204410154AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M204410152AA0: Turbo-Elite™ Laser Atherectomy Catheter
• M2044250010: Turbo-Elite™ Laser Atherectomy Catheter
• M2044230010: Turbo-Elite™ Laser Atherectomy Catheter
• M2044201590: Turbo-Elite™ Laser Atherectomy Catheter
• M2044200060: Turbo-Elite™ Laser Atherectomy Catheter
• M2044171560: Turbo-Elite™ Laser Atherectomy Catheter
• M2044171520: Turbo-Elite™ Laser Atherectomy Catheter
• M2044141590: Turbo-Elite™ Laser Atherectomy Catheter
• M2044141510: Turbo-Elite™ Laser Atherectomy Catheter
• M2044101540: Turbo-Elite™ Laser Atherectomy Catheter
• M2044101520: Turbo-Elite™ Laser Atherectomy Catheter