NAUTILUS

GUDID 08053307590196

Fixed equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc

TECHNIX SPA

Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 08053307590196
• NIH Device Record Key: f861a629-d3be-4c90-a103-d2238467362d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAUTILUS
• Version Model Number: NAUTILUS
• Company DUNS: 437977127
• Company Name: TECHNIX SPA
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08053307590196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220871

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2024-11-14
• Device Publish Date: 2024-11-06

Devices Manufactured by TECHNIX SPA

• 08053307590196 - NAUTILUS: 2024-11-14Fixed equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc
• 08053307590196 - NAUTILUS: 2024-11-14 Fixed equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc
• 08053307591070 - TRIDENT: 2024-11-14 Mobile equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc
• 08053307591087 - TRIDENT: 2024-11-14 Mobile equipment for radioscopy and radiography Brand: Dornier MedTech America, Inc