Stealth 7-10059-02

GUDID 10850000491271

STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT

Cardiovascular Systems, Inc.

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 10850000491271
• NIH Device Record Key: 2321f8db-b896-49d3-a70a-0517f1604b7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stealth
• Version Model Number: PRD-SC30-125
• Catalog Number: 7-10059-02
• 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: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com
• Phone: 877-274-0360
• Email: customerservice@csi360.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10850000491271 [Primary]

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

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

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

[10850000491271]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [Stealth]

• 10850000491349: STEALTH PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
• 10850000491332: STEALTH PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
• 10850000491325: STEALTH Peripheral, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
• 10850000491318: STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
• 10850000491301: STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
• 10850000491295: STEALTH PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
• 10850000491288: STEALTH PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
• 10850000491271: STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
• 10850000491264: STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
• 10850026568711: STEALTH, 2.00 MAX CROWN, 145CM SHAFT
• 10852528005770: Stealth, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
• 10852528005763: Stealth, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
• 10852528005756: Stealth, Radial Access OAD, 1.25mm, 10mm, 200cm shaft
• 10852528005343: STEALTH, SOLID, 2.25MM, 145CM SHAFT
• 10852528005060: STEALTH, SOLID MICRO, 1.25MM, 145CM SHAFT
• 10852528005053: STEALTH, SOLID, 2.00MM, 145CM SHAFT
• 10852528005046: STEALTH, SOLID, 1.50MM, 145CM SHAFT
• 10852528005039: STEALTH, SOLID, 1.25MM, 145CM SHAFT
• 10852528005022: STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
• 10852528005015: STEALTH, CLASSIC, 1.50MM, 145CM SHAFT