Owandy Radiology

GUDID 08052870660718

DENTAL XRAY COMPANY SRL

Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue Stationary intraoral dental x-ray system, analogue

• Primary Device ID: 08052870660718
• NIH Device Record Key: 664e3b4f-f591-463d-a77c-d9fb6089a34e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Owandy Radiology
• Version Model Number: Elios
• Company DUNS: 439922846
• Company Name: DENTAL XRAY COMPANY SRL
• 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	08052870660718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030185

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: 2019-07-09
• Device Publish Date: 2019-07-01

Devices Manufactured by DENTAL XRAY COMPANY SRL

• 08052870660015 - Acteon: 2019-07-09
• 08052870660022 - Acteon: 2019-07-09
• 08052870660213 - Dental X-Ray Company: 2019-07-09
• 08052870660312 - Dental X-Ray Company: 2019-07-09
• 08052870660411 - Dental X-Ray Company: 2019-07-09
• 08052870660510 - Dental X-Ray Company: 2019-07-09
• 08052870660619 - Dental X-Ray Company: 2019-07-09
• 08052870660718 - Owandy Radiology: 2019-07-09
• 08052870660718 - Owandy Radiology: 2019-07-09