Philips Healthcare 014R

GUDID 57613327664084

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Intravascular ultrasound imaging catheter, reprocessed

• Primary Device ID: 57613327664084
• NIH Device Record Key: c86ab68e-56de-4d12-a666-a8589c06a11d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Healthcare
• Version Model Number: 014R
• Catalog Number: 014R
• Company DUNS: 020198912
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327664089 [Primary]
GS1	57613327664084 [Package]; Contains: 07613327664089; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200195

FDA Product Code

• OWB: Interventional fluoroscopic x-ray system

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: 2025-02-19
• Device Publish Date: 2025-02-11

On-Brand Devices [Philips Healthcare]

• 57613327664114: Philips Visions PV .035 OTW Peripheral Vascular Catheter
• 57613327664107: 85900PST
• 57613327664091: 85900P
• 57613327664084: 014R