CORE Control Pad 2.0

GUDID 00845225012823

VOLCANO CORPORATION

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• Primary Device ID: 00845225012823
• NIH Device Record Key: afea3228-f7f9-4881-9bc1-6d16bda0382c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE Control Pad 2.0
• Version Model Number: 409-1601.04
• 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	00845225012823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153369

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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