C015

GUDID 08053470960017

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images

MICRONICA SRL

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 08053470960017
• NIH Device Record Key: 672b015a-915c-42ef-bfde-14eda41e1a63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C015
• Version Model Number: FP XL C015
• Company DUNS: 428699566
• Company Name: MICRONICA SRL
• 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: true
• 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	08053470960017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192182

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: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [C015]

• 08053470960017: Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic
• 08053470960000: Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic