Duns Number:078375583
Device Description: Pullout Keyboard Tray, 21" W extends 10", requires 22" shelf (PMSH) for mounting, includes Pullout Keyboard Tray, 21" W extends 10", requires 22" shelf (PMSH) for mounting, includes L/R mouse tray.
Catalog Number
-
Brand Name
Skytron 22" pullout KB tray w/mouse E3
Version/Model Number
H8-300-27-A
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQO
Product Code Name
Table, Operating-Room, Ac-Powered
Public Device Record Key
e16e9914-ef8c-4716-bf3e-4aa49c8fa53b
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 747 |
2 | A medical device with a moderate to high risk that requires special controls. | 265 |