UDI device identifier

Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 1

UDI device identifier 00884838080805 · Philips Medical Systems Nederland B.V.

Key facts

Primary DI 00884838080805
Brand name Dynamic Coronary Roadmap
Version or model Dynamic Coronary Roadmap - 1
Catalog number 001016
Company Philips Medical Systems Nederland B.V.
DUNS number 413819707
Product code OWB
GMDN term Cardiovascular fluoroscopy/intravascular imaging software
Premarket submission K170130
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jun 29, 2017
Version date Sep 4, 2026
Description Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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