Duns Number:006375677
Device Description: Disposable barrier covered Troop Elevation Pillow - 4 per box
Catalog Number
10-910-00
Brand Name
Disposable Troop Elevation Pillow
Version/Model Number
10-910-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2021
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"
Yes
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
15b098d1-ff29-427c-9ba5-0814ccb9aa85
Public Version Date
September 15, 2021
Public Version Number
2
DI Record Publish Date
April 14, 2020
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 | 7 |