SyncVision Workstation

GUDID 00845225012830

VOLCANO CORPORATION

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• Primary Device ID: 00845225012830
• NIH Device Record Key: 272ca8ca-a236-47f9-bb67-3dc526f9bf36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SyncVision Workstation
• Version Model Number: 300000467271
• Company DUNS: 135179237
• Company Name: VOLCANO CORPORATION
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225012830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132558

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-07

On-Brand Devices [SyncVision Workstation]

• 00845225012830: 300000467271
• 00845225012441: 411-0100.04