Diamondback Coroanry 70058-12

GUDID 10852528005428

CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM

Cardiovascular Systems, Inc.

Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 10852528005428
• NIH Device Record Key: 1767bc5f-d535-49d2-a583-473bca723fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamondback Coroanry
• Version Model Number: DBEC-125
• Catalog Number: 70058-12
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10852528005428 [Primary]

FDA Product Code

• MCX: Catheter, Coronary, Atherectomy

Sterilization

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

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

[10852528005428]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-12-18
• Device Publish Date: 2017-11-02

Devices Manufactured by Cardiovascular Systems, Inc.

• 10852528005169 - Diamondback Coronary: 2023-12-18 DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
• 10852528005176 - Diamondback Coronary: 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
• 30852528005187 - Diamondback Coronary: 2023-12-18 Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
• 10852528005336 - Diamondback Coronary: 2023-12-18 DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown
• 10852528005428 - Diamondback Coroanry: 2023-12-18CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
• 10852528005428 - Diamondback Coroanry: 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
• 10852528005787 - Diamondback Coronary: 2023-12-18 CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
• 10852528005800 - Diamondback Coronary: 2023-12-18 SALINE INFUSION PUMP (SIP)
• 10852528005442 - Diamondback Coronary: 2023-12-11 SALINE INFUSION PUMP (SIP)