ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor

GUDID 00184360000334

VOLCANO CORPORATION

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• Primary Device ID: 00184360000334
• NIH Device Record Key: 181d4bfc-2b48-4d2a-b07d-ba887b9ac90a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor
• Version Model Number: 9515
• 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: true
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00184360000334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042996

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

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