StentBoost 718160

GUDID 00884838103450

StentBoost Mobile is a software product intended to provide a high resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.

Philips India Limited

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• Primary Device ID: 00884838103450
• NIH Device Record Key: 321c0de1-0f33-4b6f-9504-8e24471cac21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StentBoost
• Version Model Number: StentBoost Mobile
• Catalog Number: 718160
• Company DUNS: 650958353
• Company Name: Philips India Limited
• 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	00884838103450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203623

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-23
• Device Publish Date: 2021-06-15