RAYSCAN α +

GUDID 08800003001187

Ray Co., Ltd

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• Primary Device ID: 08800003001187
• NIH Device Record Key: bceca872-33e5-4604-8565-4414f82a270b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN α +
• Version Model Number: RCT700-CT
• 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	08800003001187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182614

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-12
• Device Publish Date: 2018-11-07

Devices Manufactured by Ray Co., Ltd

• 08800003000241 - RAYSCAN α-Expert: 2024-05-06
• 08800003000258 - RAYSCAN α-Expert: 2024-05-06
• 08800003000265 - RAYSCAN α-Expert: 2024-05-06
• 08800003000272 - RAYSCAN α-Expert: 2024-05-06
• 08800003000289 - RAYSCAN α-Expert: 2024-05-06
• 08800003000296 - RAYSCAN α-Expert: 2024-05-06
• 08800003000302 - RAYSCAN α-Expert: 2024-05-06
• 08800003000319 - RAYSCAN α-Expert: 2024-05-06