VSI StraitSet™ micro-introducer kit

GUDID M20679650

Vascular Solutions, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: M20679650
• NIH Device Record Key: d8795983-fc28-4f78-8ed9-56b1fa894717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSI StraitSet™ micro-introducer kit
• Version Model Number: 7961
• Company DUNS: 008999906
• Company Name: Vascular Solutions, 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: true
• 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: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Dimensions

• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French
• Length: 20 Centimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20679650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071330

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-08-09

On-Brand Devices [VSI StraitSet™ micro-introducer kit]

• M20679710: 7961
• M20679650: 7961
• M20679640: 7960
• M20679620: 7960
• M20679610: 7961
• M20679600: 7960