Duns Number:023904428
Device Description: Foam Cushion HIGH DENSITY POLYURETHANE FOAM 16" x 16" x 3"
Catalog Number
-
Brand Name
McKesson
Version/Model Number
170-71001
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
2e5714e2-b19d-43f1-bb61-210fc07ccb5d
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
April 30, 2019
Package DI Number
00612479220744
Quantity per Package
5
Contains DI Package
00612479220737
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 |