Dynamic Coronary Roadmap 001016

GUDID 00884838080805

Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software

• Primary Device ID: 00884838080805
• NIH Device Record Key: 33e5758f-53da-45c7-b83c-6b3c1cf6ed05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamic Coronary Roadmap
• Version Model Number: Dynamic Coronary Roadmap R1
• Catalog Number: 001016
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00884838080805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170130

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-24
• Device Publish Date: 2017-06-29

On-Brand Devices [Dynamic Coronary Roadmap]

• 00884838086777: Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a
• 00884838080805: Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a
• 00884838101883: Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a