Duns Number:023904428
Device Description: WHEELCHAIR, CRUISER III 18" FLIP BCK ARM STYLES BLK
Catalog Number
-
Brand Name
McKesson
Version/Model Number
146-K318ADDA-ELR
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
K082784
Product Code
IOR
Product Code Name
Wheelchair, Mechanical
Public Device Record Key
333c8b81-4b4a-4be3-a23b-69f12edd0e23
Public Version Date
September 26, 2019
Public Version Number
1
DI Record Publish Date
September 18, 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 |