Crosser iQ XCTO146

GUDID 00801741201332

Crosser iQ Ultrasonic CTO Device

Bard Peripheral Vascular, Inc.

Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral Mechanical atherectomy system catheter, coronary/peripheral

• Primary Device ID: 00801741201332
• NIH Device Record Key: ee147d27-b0e9-485c-b5f8-784d03dafaa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crosser iQ
• Version Model Number: XCTO146
• Catalog Number: XCTO146
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com

Device Dimensions

• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter
• Length: 146 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741201332 [Primary]

FDA Product Code

• PDU: Catheter for crossing total occlusions

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: 2021-10-12
• Device Publish Date: 2021-10-04

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• 00801741213922 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 100mm, 130cm Catheter
• 00801741213939 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 120mm, 130cm Catheter
• 00801741213946 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 3.5mm x 150mm, 130cm Catheter
• 00801741213953 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 4.0mm x 20mm, 130cm Catheter
• 00801741213960 - Highlander: 2023-03-13 Highlander 014 PTA Balloon Dilatation Catheter 4.0mm x 40mm, 130cm Catheter