uDR

GUDID 06971576833276

Shanghai United Imaging Healthcare Co., Ltd.

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• Primary Device ID: 06971576833276
• NIH Device Record Key: cccd4c7c-da81-4c71-b8f8-c8cf83ed8764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uDR
• Version Model Number: uDR 380i Pro
• Company DUNS: 421271328
• Company Name: Shanghai United Imaging Healthcare Co., Ltd.
• 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: false
• 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	06971576833276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222339

FDA Product Code

• IZL: System, X-Ray, 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: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [uDR]

• 06971576833023: Digital Medical X-ray Imaging System
• 06971576833276: uDR 380i Pro
• 06971576833061: Digital Medical X-ray Imaging System