Duns Number:080143399
Device Description: The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a w The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame.
Catalog Number
-
Brand Name
Accent 1400 Keyguard 28 Location
Version/Model Number
17342-28
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
8ecbd236-f7a0-4a3d-aac2-ddb1765e905c
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 |