Duns Number:023904428
Device Description: Seat Cushion McKesson 18 W X 16 D X 3 H Inch Foam
Catalog Number
-
Brand Name
McKesson
Version/Model Number
136-58132
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"
Yes
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
3af51d14-f581-4ddd-9783-51c90be9669f
Public Version Date
April 12, 2019
Public Version Number
1
DI Record Publish Date
April 04, 2019
Package DI Number
00612479191563
Quantity per Package
18
Contains DI Package
00612479191556
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |