Duns Number:132016168
Device Description: CASTER 8X2 WHL&FORK
Catalog Number
90763440
Brand Name
Everest & Jennings
Version/Model Number
90763440
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2021
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNN
Product Code Name
Components, Wheelchair
Public Device Record Key
5416afb1-f502-42d5-b9f8-2107fdf0c134
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 2021
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 | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 202 |