Duns Number:023904428
Device Description: Full Reclining Wheelchair, 20 Inches DETACHABLE DESK ARMS SWING-AWAY ELEVATING LEG REST Full Reclining Wheelchair, 20 Inches DETACHABLE DESK ARMS SWING-AWAY ELEVATING LEG RESTS
Catalog Number
-
Brand Name
McKesson
Version/Model Number
146-SSP20RBDDA
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
ec5dd877-0995-443e-87b4-11acd0e61650
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 11, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |