Catalog Number

12006977

Brand Name

Tobii Dynavox

Version/Model Number

I-16

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILQ

Product Code Name

System, Communication, Powered

Public Device Record Key

0f9f43c3-c4e8-42db-8d39-4d1247f129fa

Public Version Date

March 04, 2020

Public Version Number

2

DI Record Publish Date

October 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-