Duns Number:080143399
Device Description: Keyguards are made from thick, clear polycarbonate material and precisely engineered to he Keyguards are made from thick, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. Keyguards allow the Accent 800/800-D to be set up to accommodate a wide range of cognitive and motor skills. Using the Keyguard with the 800 requires the device frame that came with the 800. If a replacement frame is needed please go to (insert link to 800 Device Frame)These keyguards have rectangular openings as shown in the picture and are made from clear .183" thick polycarbonate.
Catalog Number
-
Brand Name
Accent 800 Keyguard 8 Location
Version/Model Number
17348-8
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)
Yes
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
bcd02f30-e53c-4e21-a97a-0f7a8de171e9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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. | 198 |