Nical Smart Micro NPR1000AA

GUDID 08056600521348

NICAL SPA

Dental computed radiography digital imaging scanner

• Primary Device ID: 08056600521348
• NIH Device Record Key: f1c2c534-efad-47aa-b376-76f5a12cd5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nical Smart Micro
• Version Model Number: NPR System
• Catalog Number: NPR1000AA
• 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	08056600521348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143703

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Nical Smart Micro]

• 08056600521355: NPR System
• 08056600521348: NPR System
• 08056600521331: NPR System
• 08056600520037: NPR System
• 08056600520020: NPR System
• 08056600520013: NPR System
• 08056600520006: NPR System