SurgicalPreview SURGICALPREVIEW220

GUDID B642SURGICALPREVIEW2100

Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac OSX based com

ENDOVANTAGE LLC

Vascular modelling web-based application software

• Primary Device ID: B642SURGICALPREVIEW2100
• NIH Device Record Key: 1e697bbd-d972-429a-8de2-52c98d76976f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgicalPreview
• Version Model Number: 2.2.0
• Catalog Number: SURGICALPREVIEW220
• Company DUNS: 079324339
• Company Name: ENDOVANTAGE LLC
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B642SURGICALPREVIEW2100 [Previous]
HIBCC	B642SURGICALPREVIEW2200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171534

FDA Product Code

• PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-07
• Device Publish Date: 2018-12-07

On-Brand Devices [SurgicalPreview]

• B642SURGICALPREVIEW2300: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2200: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2100: Device Description (max 2000 characters): SurgicalPreview is a stand-alone software application
• B642SURGICALPREVIEW1200: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW1100: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW100: SurgicalPreview is a stand-alone software application that runs on any standard Windows or Mac O
• B642SURGICALPREVIEW2400: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW2500: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW2600: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3000: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3100: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac
• B642SURGICALPREVIEW3200: SurgicalPreview® is a stand-alone software application that runs on any standard Windows or Mac