CORE Control Pad 2.0 400-1610.02

GUDID 00845225012779

Philips Image Guided Therapy Corporation

Cardiovascular ultrasound imaging system

• Primary Device ID: 00845225012779
• NIH Device Record Key: f532bf0d-5a70-464c-ba20-a1f21ff4382a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE Control Pad 2.0
• Version Model Number: 400-1610.02
• Catalog Number: 400-1610.02
• Company DUNS: 018860556
• Company Name: Philips Image Guided Therapy 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	00845225012779 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-29
• Device Publish Date: 2021-11-19

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• 00845225003371 - Eagle Eye Platinum ST RX Digital IVUS Catheter: 2025-10-02 Eagle Eye Platinum short tip rapid exchange digital intravascular ultrasound catheter
• 00845225012984 - Patient Interface Module (PIMr): 2025-09-01 Patient interface module for rotational intravascular ultrasound catheters
• 00845225003425 - Pioneer Plus Catheter: 2024-08-20
• 20813132029412 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029429 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029436 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter