STEPHANIX 95 02 000

GUDID 08055186670303

This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 08055186670303
• NIH Device Record Key: f598004f-7c64-4127-9ae5-c9fdd039f05b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEPHANIX
• Version Model Number: OMNISCOP Dream-S
• Catalog Number: 95 02 000
• Company DUNS: 440069847
• Company Name: A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI 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	08055186670303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211777

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: 2021-09-28
• Device Publish Date: 2021-09-20

On-Brand Devices [STEPHANIX]

• 08055186670303: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
• 08055186670297: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
• 08055186670242: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
• 08055186670235: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
• 08055186670228: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu
• 08055186670211: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visu