Duns Number:827221698
Catalog Number
-
Brand Name
WHEELCHAIR CUSHION FOAM - 16x16x3
Version/Model Number
WCF-163
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)
Yes
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
ef80fcf4-d19c-486d-bf37-374df5e6df40
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
80092237604171
Quantity per Package
12
Contains DI Package
00092237604175
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARDBOARD CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |
U | Unclassified | 2 |