Veradius 718132

GUDID 00884838058194

Mobile, diagnostic X-ray imaging and viewing system with Flat Detector. Used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures.

Philips Medical Systems Nederland B.V.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00884838058194
• NIH Device Record Key: 8b524ab2-bd81-42cd-b890-799dfd37bc23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veradius
• Version Model Number: Veradius Unity
• Catalog Number: 718132
• 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: false
• Serial Number: true
• 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	00884838058194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142708

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: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Veradius]

• 00884838058194: Mobile, diagnostic X-ray imaging and viewing system with Flat Detector. Used for radiological gu
• 00884838044302: Mobile, diagnostic X-ray imaging and viewing system with Flat Detector. Used for radiological gu