N33 CCD System N331R1CLA

GUDID 08056600520815

NICAL SPA

Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit

• Primary Device ID: 08056600520815
• NIH Device Record Key: 36ab3abe-a26b-4890-9d80-c820d07c09c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N33 CCD System
• Version Model Number: N33
• Catalog Number: N331R1CLA
• 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	08056600520815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951261

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: 2023-10-19
• Device Publish Date: 2023-10-11

On-Brand Devices [N33 CCD System]

• 08056600521324: N33
• 08056600520884: N33
• 08056600520877: N33
• 08056600520860: N33
• 08056600520853: N33
• 08056600520846: N33
• 08056600520839: N33
• 08056600520822: N33
• 08056600520815: N33
• 08056600520808: N33
• 08056600520792: N33
• 08056600520785: N33
• 08056600520778: N33
• 08056600520761: N33
• 08056600520754: N33
• 08056600520747: N33
• 08056600520730: N33
• 08056600520723: N33
• 08056600520716: N33
• 08056600520709: N33
• 08056600520693: N33
• 08056600520686: N33
• 08056600520679: N33
• 08056600520662: N33
• 08056600520655: N33
• 08056600520648: N33
• 08056600520631: N33
• 08056600520624: N33
• 08056600520617: N33
• 08056600520600: N33
• 08056600520594: N33
• 08056600520587: N33
• 08056600520570: N33
• 08056600520563: N33
• 08056600520556: N33
• 08056600520549: N33