RAYSCAN α

GUDID 08800003000043

Ray Co., Ltd

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• Primary Device ID: 08800003000043
• NIH Device Record Key: c4754e69-9885-4ee0-8aa2-32a375306383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYSCAN α
• Version Model Number: OCS
• 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	08800003000043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142058

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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 [RAYSCAN α]

• 08800003000142: Up grade Kit - OCS
• 08800003000135: Up grade Kit - OCL
• 08800003000128: Up grade Kit - SC
• 08800003000111: Up grade Kit - CT
• 08800003000104: M3DS
• 08800003000098: M3DL
• 08800003000081: SM3D
• 08800003000074: 3D (Pano)
• 08800003000067: 3D (CT+Pano)
• 08800003000050: OCL
• 08800003000043: OCS
• 08800003000036: SC
• 08800003000029: P