StentBoost Live 001017

GUDID 00884838080812

Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents.

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838080812
NIH Device Record Key80064c6b-a9b5-4af5-b1e1-f08bec5c7346
Commercial Distribution StatusIn Commercial Distribution
Brand NameStentBoost Live
Version Model NumberStentBoost Live R1
Catalog Number001017
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838080812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-24
Device Publish Date2017-06-29

On-Brand Devices [StentBoost Live]

00884838080812Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enh
00884838101890Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enh

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