DURAY DURAY V2

GUDID 00990010301306

DURAY V2, DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length

Beyes Dental Canada Inc

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00990010301306
• NIH Device Record Key: 5b76b0a9-cb60-4174-b215-54cd8f081d36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAY
• Version Model Number: XR2011
• Catalog Number: DURAY V2
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990010301306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031118

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2023-05-19
• Device Publish Date: 2023-05-11

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