DC-Air™ Intraoral Sensor

GUDID 06429810587220

DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

Athlos Oy

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• Primary Device ID: 06429810587220
• NIH Device Record Key: faf5e834-1b06-4b5b-bb6d-370b63f634ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-Air™ Intraoral Sensor
• Version Model Number: WIOS-S2-BLACK
• Company DUNS: 368444471
• Company Name: Athlos Oy
• 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	06429810587213 [Primary]
GS1	06429810587220 [Package]; Contains: 06429810587213; Package: [1 Units]; In Commercial Distribution

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: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [DC-Air™ Intraoral Sensor]

• 64298105870606: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of
• 06429810587008: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of
• 06429810587220: DC-Air™ Intraoral Sensor is intended for radiographic examination to assist with diagnosis of