Smart-C

GUDID 00850003909028

TURNER IMAGING SYSTEMS

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00850003909028
• NIH Device Record Key: d9e0e4dd-d46f-4d85-bb30-6cc69eb574d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart-C
• Version Model Number: Monitor Cart for Smart-C
• Company DUNS: 080599056
• Company Name: TURNER IMAGING SYSTEMS
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003909028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190024

FDA Product Code

• OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

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: 2020-07-24
• Device Publish Date: 2020-07-16

On-Brand Devices [Smart-C]

• 00850003909028: Monitor Cart for Smart-C
• 00850003909011: Support Stand for Smart-C
• 00850003909004: Smart-C Mini C-Arm Imaging System