Tobii Dynavox - Speech Generating Device with a 10" in touch - TOBII DYNAVOX LLC

Duns Number:119127942

Device Description: Speech Generating Device with a 10" in touch screen. Tablet style unit, water resistant a Speech Generating Device with a 10" in touch screen. Tablet style unit, water resistant and durable with high quality speakers. Generally includes SNAP, COMPASS or Communicator Software

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More Product Details

Catalog Number

12004860

Brand Name

Tobii Dynavox

Version/Model Number

I-110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 22, 2022

Issuing Agency

In GS1

Product Characteristics

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

Yes

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 Details

Product Code

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

d30b6965-2ff1-4c89-8e4c-6f424ed40d0b

Public Version Date

September 02, 2022

Public Version Number

3

DI Record Publish Date

October 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOBII DYNAVOX LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35