N23 CCD System N2350RHN1

GUDID 08056600520273

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 Fluoroscopic x-ray system video image recording unit

• Primary Device ID: 08056600520273
• NIH Device Record Key: 21c807a2-16fb-49ab-920f-219a290452f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N23 CCD System
• Version Model Number: N23
• Catalog Number: N2350RHN1
• 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	08056600520273 [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: 2023-10-17
• Device Publish Date: 2023-10-09

On-Brand Devices [N23 CCD System]

• 08056600520297: N23
• 08056600520280: N23
• 08056600520273: N23
• 08056600520266: N23
• 08056600520259: N23
• 08056600520242: N23
• 08056600520235: N23
• 08056600520228: N23
• 08056600520211: N23
• 08056600520204: N23
• 08056600520198: N23
• 08056600520181: N23
• 08056600520174: N23
• 08056600520167: N23
• 08056600520150: N23
• 08056600520143: N23
• 08056600520136: N23
• 08056600520129: N23
• 08056600520112: N23
• 08056600520105: N23
• 08056600520099: N23
• 08056600520082: N23
• 08056600520075: N23
• 08056600520068: N23
• 08056600521317: N23
• 08056600521300: N23
• 08056600521256: N23
• 08056600521249: N23
• 08056600521232: N23
• 08056600521225: N23
• 08056600521218: N23
• 08056600521201: N23
• 08056600520891: N23
• 08056600520532: N23
• 08056600520525: N23
• 08056600520518: N23
• 08056600520501: N23
• 08056600520495: N23
• 08056600520488: N23
• 08056600520471: N23
• 08056600520464: N23
• 08056600520457: N23
• 08056600520440: N23
• 08056600520433: N23
• 08056600520426: N23
• 08056600520419: N23
• 08056600520402: N23
• 08056600520396: N23
• 08056600520389: N23
• 08056600520372: N23