CORE Control Pad 2.0 400-1610.02

GUDID 00845225012779

Philips Image Guided Therapy Corporation

Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system Cardiovascular ultrasound imaging system 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

Devices Manufactured by Philips Image Guided Therapy Corporation

• 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
• 20813132029443 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029450 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 00813132029463 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029474 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter
• 20813132029481 - Quick-Cross Extreme: 2023-10-12 Quick-Cross Extreme Support Catheter