Catalog Number

IT17-001

Brand Name

ITA.O

Version/Model Number

Maschera facciale ortodontica - MAXI - Bianco

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202855

Product Code

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Public Device Record Key

09d1529e-2724-4ec7-aeb7-736e058f9f7f

Public Version Date

November 25, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-