Duns Number:867673159
Device Description: Pressure PreventionRetail Foam Product Description: WedgeWheelchairCushion18x16x3-1 1ea,4/ Pressure PreventionRetail Foam Product Description: WedgeWheelchairCushion18x16x3-1 1ea,4/CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
8134
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMP
Product Code Name
CUSHION, WHEELCHAIR
Public Device Record Key
14182111-b635-4984-9719-d402d92f97fd
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
May 19, 2017
Package DI Number
50822383515866
Quantity per Package
4
Contains DI Package
00822383515861
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |