RAYiOS

GUDID 08800160000023

DDS INC

Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system

• Primary Device ID: 08800160000023
• NIH Device Record Key: a1309ba0-093b-4cde-b26f-4b49905d6c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAYiOS
• Version Model Number: COMFORT+
• Company DUNS: 688424199
• Company Name: DDS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	08800160000023 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2022-05-27
• Device Publish Date: 2022-05-19

Devices Manufactured by DDS INC

• 08800160000030 - RAYiOS2: 2023-08-22
• 08800160000016 - COMFORT+: 2022-05-27
• 08800160000023 - RAYiOS: 2022-05-27
• 08800160000023 - RAYiOS: 2022-05-27
• 18800160000006 - COMFORT+: 2021-11-05