Duns Number:119127942
Device Description: SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/GOLD TABLET
Catalog Number
800742
Brand Name
Tobii Dynavox
Version/Model Number
SC Tablet
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2019
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
a91a9e98-6e9c-4f99-b080-e3f96252a930
Public Version Date
September 02, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 35 |