Diamondback Coronary 7-10098-01

GUDID 10850026568698

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT

Cardiovascular Systems, Inc.

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 10850026568698
• NIH Device Record Key: 7313e986-860f-4f19-9197-f381273a8abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamondback Coronary
• Version Model Number: DBEC-125
• Catalog Number: 7-10098-01
• Company DUNS: 024954518
• Company Name: Cardiovascular Systems, 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: 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: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com
• Phone: 651-259-1600
• Email: customerservice@csi360.com

Device Dimensions

• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0
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• Shaft Length: 135 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850026568698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130005

FDA Product Code

• MCX: Catheter, Coronary, 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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [Diamondback Coronary]

• 30852528005705: Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
• 10850000491363: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
• 10850000491356: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
• 10850026568100: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
• 10850026568087: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
• 10850026568698: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
• 10852528005442: SALINE INFUSION PUMP (SIP)
• 10852528005800: SALINE INFUSION PUMP (SIP)
• 10852528005787: CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
• 10852528005336: DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown
• 30852528005187: Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
• 10852528005176: CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
• 10852528005169: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM