Nical Flat Panel NFPMD4335

GUDID 08056600520051

NICAL SPA

Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner

• Primary Device ID: 08056600520051
• NIH Device Record Key: 203dfdf4-6684-4969-b7a9-e61964f75dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nical Flat Panel
• Version Model Number: NFP Digital detector
• Catalog Number: NFPMD4335
• Company DUNS: 435743877
• Company Name: NICAL 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: true
• 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	08056600520051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053029

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-10-17
• Device Publish Date: 2023-10-09

On-Brand Devices [Nical Flat Panel]

• 08056600520051: NFP Digital detector
• 08056600520044: NFP Digital detector