Duns Number:958758146
Device Description: Foam Wheelchair Cushion (16" x 18" x 4")
Catalog Number
WCC16184
Brand Name
Wheelchair Cushion
Version/Model Number
WCC16184
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
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
fcfeee64-d316-4343-820d-d2e86fe60d23
Public Version Date
July 27, 2021
Public Version Number
3
DI Record Publish Date
February 20, 2019
Package DI Number
00810006683448
Quantity per Package
18
Contains DI Package
00810006682441
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Each
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 208 |