RIOSensor

GUDID 08800003002023

Ray Co., Ltd

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• Primary Device ID: 08800003002023
• NIH Device Record Key: 41317684-71cf-4e9d-b499-77f4975ef184
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIOSensor
• Version Model Number: RIO500 (size 2)
• Company DUNS: 690324087
• Company Name: Ray 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: 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	08800003002023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143000

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-12
• Device Publish Date: 2016-10-05

On-Brand Devices [RIOSensor]

• 08800003002023: RIO500 (size 2)
• 08800003002016: RIO500 (size 1)