ITA.O IT17-002B

GUDID 08052675320015

ITA.O ITALIAN ORTHODONTIC SYSTEM SRL

Orthodontic extraoral headgear

• Primary Device ID: 08052675320015
• NIH Device Record Key: 0f528a5b-dbc0-4295-9b0f-a0c73c947659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITA.O
• Version Model Number: Maschera facciale MINI Blu
• Catalog Number: IT17-002B
• Company DUNS: 513891569
• Company Name: ITA.O ITALIAN ORTHODONTIC SYSTEM 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: true
• Serial Number: false
• 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	08052675320015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202855

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

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: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [ITA.O]

• 08052675320091: Maschera facciale MAXI Verde
• 08052675320084: Maschera facciale MAXI Rosso
• 08052675320077: Maschera facciale MAXI Giallo
• 08052675320060: Maschera facciale MAXI Blu
• 08052675320053: Maschera facciale MAXI Bianco
• 08052675320046: Maschera facciale MINI Verde
• 08052675320039: Maschera facciale MINI Rosso
• 08052675320022: Maschera facciale MINI Giallo
• 08052675320015: Maschera facciale MINI Blu
• 08052675320008: Maschera facciale MINI Bianco