Nical Flat Panel NF3024C00

GUDID 08056600520044

NICAL SPA

Computed radiography digital imaging scanner

• Primary Device ID: 08056600520044
• NIH Device Record Key: d96b5c06-e635-4975-ab46-fd21a5864a62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nical Flat Panel
• Version Model Number: NFP Digital detector
• Catalog Number: NF3024C00
• 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	08056600520044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053029

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

On-Brand Devices [Nical Flat Panel]

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