Vi-Radius

GUDID B293VR014300G0

Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten coil on the distal tip. The distal portion of the wire

MIVI NEUROVASCULAR

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: B293VR014300G0
• NIH Device Record Key: 68c99ee6-0199-4742-a081-183832a46190
• Commercial Distribution Discontinuation: 2019-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vi-Radius
• Version Model Number: VR014300G
• Company DUNS: 076836823
• Company Name: MIVI NEUROVASCULAR
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

• Length: 300 Centimeter
• Length: 300 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B293VR014300G0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151825

FDA Product Code

• MOF: Guide, Wire, Catheter, Neurovasculature

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-11
• Device Publish Date: 2016-09-28

On-Brand Devices [Vi-Radius]

• B293VR014300G0: Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten co
• B293VR014205G0: Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten co