Pioneer Plus Catheter PPLUS120

GUDID 00845225003425

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00845225003425
• NIH Device Record Key: dd6fc5b2-340b-4e4c-a1cb-1bfe27110f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pioneer Plus Catheter
• Version Model Number: PPLUS120
• Catalog Number: PPLUS120
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com
• Phone: (800) 228-4728
• Email: IGTD.CustomerInquiry@philips.com

Device Dimensions

• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter
• Length: 120 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162418

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-20
• Device Publish Date: 2024-08-12

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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
• 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