DURAY

GUDID 00837699000109

DC1, Duray Scanner DC1 Package

Beyes Dental Canada Inc

Dental computed radiography digital imaging scanner

• Primary Device ID: 00837699000109
• NIH Device Record Key: bf7535f4-a407-42c2-97a1-7b168366d6a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAY
• Version Model Number: DC1001
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• 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	00837699000109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212080

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [DURAY]

• 00837699000116: DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
• 00837699000093: DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
• 00837699000109: DC1, Duray Scanner DC1 Package
• 00837699000086: DS2, Duray Sensor Size 2 Kit
• 00837699000079: DS1, Duray Sensor Size 1 Kit
• 00990010301276: DS2, Duray Sensor Size 2 Kit
• 00990010301269: DS1, Duray Sensor Size 1 Kit
• 00990010301306: DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
• 00990010301290: DC1, Duray Scanner DC1 Package
• 00990010301283: DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length