Villa Sistemi Medicali

GUDID 08057737122361

VILLA SISTEMI MEDICALI SPA

Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 08057737122361
• NIH Device Record Key: b27a9be2-5ef1-40f9-9767-04ef76a6aec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Villa Sistemi Medicali
• Version Model Number: DRF 4343-TS
• Company DUNS: 439173964
• Company Name: VILLA SISTEMI MEDICALI 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: 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	08057737122361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080859

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [Villa Sistemi Medicali]

• 08057737122361: DRF 4343-TS
• 08057737122262: DRF 4343 FL
• 08057737122217: DRF 4343