Owandy Radiology 9458100100

GUDID 03760262651019

Opteo size 1

OWANDY RADIOLOGY

Dental digital imaging sensor, intraoral

• Primary Device ID: 03760262651019
• NIH Device Record Key: db616df9-7397-4b8a-98ed-fb21b922a277
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Owandy Radiology
• Version Model Number: Opteo
• Catalog Number: 9458100100
• Company DUNS: 265612235
• Company Name: OWANDY RADIOLOGY
• 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	03760262651019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133271

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: 5
• Public Version Date: 2023-06-12
• Device Publish Date: 2016-09-24

On-Brand Devices [Owandy Radiology]

• 03760262652351: Owandy- CR V2 Ethernet (REF.9458900031)
• 03760262652337: Owandy-CR V2 USB (REF.9458900021)
• 03760262651811: I-MAX 3D PAN ONLY 110-120V
• 03760262651613: I-MAX PAN ONLY 110-120V
• 03760262651125: OWANDY ONE SIZE 2
• 03760262651118: OWANDY ONE SIZE 1
• 03760262651026: Opteo size 2
• 03760262651019: Opteo size 1
• 03760262650616: Ow-RX
• 03760262650210: I-Max Touch 3D
• 03760262650012: I-Max Touch